Thursday, May 20, 2010

Part II

Consumer Product Safety Commission 16 CFR Part 1107 Testing and Labeling Pertaining to Product Certification; Proposed Rule

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CONSUMER PRODUCT SAFETY Highway, Bethesda, MD 20814; (15 U.S.C. 2052(a)(2)) defines a COMMISSION telephone (301) 504–7923. children’s product, in part, as a Instructions: All submissions received consumer product designed or intended 16 CFR Part 1107 must include the agency name and primarily for children 12 and younger.) docket number for this proposed Section 14(a)(2)(A) of the CPSA also [CPSC Docket No. CPSC–2010–0038] rulemaking. All comments received may states that, before a children’s product RIN 3041–AC71 be posted without change, including subject to a children’s product safety any personal identifiers, contact rule is imported for consumption or Testing and Labeling Pertaining to information, or other personal warehousing or distributed in Product Certification information provided, to http:// commerce, the manufacturer or private www.regulations.gov. Do not submit labeler of such children’s product must AGENCY: Consumer Product Safety confidential business information, trade submit sufficient samples of the Commission. secret information, or other sensitive or children’s product ‘‘or samples that are ACTION: Proposed rule. protected information electronically. identical in all material respects to the Such information should be submitted product’’ to an accredited ‘‘third party SUMMARY: The Consumer Product Safety in writing. conformity assessment body’’ to be ‘‘ ’’ ‘‘ ’’ Commission ( CPSC or Commission ) Docket: For access to the docket to tested for compliance with the is issuing a proposed rule that would read background documents or children’s product safety rule. Based on establish requirements for a reasonable comments received, go to http:// such testing, the manufacturer or private testing program and for compliance and www.regulations.gov. labeler, under section 14(a)(2)(B) of the continuing testing for children’s CPSA, must issue a certificate that products.1 The proposal would also FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager, certifies that such children’s product address labeling of consumer products complies with the children’s product to show that the product complies with Office of Hazard Identification and Reduction, U.S. Consumer Product safety rule based on the assessment of certification requirements under a a third party conformity assessment reasonable testing program for Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; body accredited to perform such tests. nonchildren’s products or under Section 14(d)(2)(A) of the CPSA 301–504–7562; e-mail: compliance and continuing testing for requires the Commission to initiate a [email protected]. children’s products. The proposed rule program by which a manufacturer or would implement section 14(a) and (d) SUPPLEMENTARY INFORMATION: private labeler may label a consumer of the Consumer Product Safety Act A. Statutory Authority product as complying with the (‘‘CPSA’’), as amended by section 102(b) certification requirements. This of the Consumer Product Safety Section 14(a)(1) of the CPSA, (15 provision applies to all consumer Improvement Act of 2008 (‘‘CPSIA’’). U.S.C. 2063(a)(1)), as amended by products that are subject to a product DATES: Written comments and section 102 of the CPSIA, establishes safety rule administered by the submissions in response to this notice requirements for the testing and Commission. must be received by August 3, 2010. certification of products subject to a Section 14(d)(2)(B) of the CPSA consumer product safety rule under the ADDRESSES: requires the Commission to establish You may submit comments, CPSA or similar rule, ban, standard, or identified by Docket No. CPSC–2010– protocols and standards for: regulation under any other act enforced • 0038, by any of the following methods: Ensuring that a children’s product by the Commission and which are tested for compliance with a children’s Electronic Submissions imported for consumption or product safety rule is subject to testing warehousing or distributed in Submit electronic comments in the periodically and when there has been a commerce. Under section 14(a)(1)(A) of following way: Federal eRulemaking material change in the product’s design the CPSA, manufacturers and private Portal: http://www.regulations.gov. or manufacturing process, including the labelers must issue a certificate which Follow the instructions for submitting sourcing of component parts; ‘‘shall certify, based on a test of each • comments. Testing of random samples; product or upon a reasonable testing • To ensure timely processing of Verifying that a children’s product program, that such product complies comments, the Commission is no longer tested by a conformity assessment body with all rules, bans, standards, or accepting comments submitted by complies with applicable children’s regulations applicable to the product electronic mail (e-mail) except through product safety rules; and under the CPSA or any other Act • Safeguarding against the exercise of http://www.regulations.gov. enforced by the Commission.’’ CPSC undue influence on a third party Written Submissions regulations, at 16 CFR part 1110, limit conformity assessment body by a Submit written submissions in the the certificate requirement to importers manufacturer or private labeler. following way: and domestic manufacturers. Section Section 14(d)(2)(B)(iii) of the CPSA Mail/Hand delivery/Courier (for 14(a)(1)(B) of the CPSA further requires provides for verification that a paper, disk, or CD–ROM submissions), that the certificate provided by the children’s product tested by a preferably in five copies, to: Office of the importer or domestic manufacturer conformity assessment body complies Secretary, Consumer Product Safety ‘‘specify each such rule, ban, standard, with applicable children’s product Commission, Room 502, 4330 East West or regulation applicable to the product.’’ safety rules. At this time, the The certificate described in section Commission is not imposing any 1 The Commission voted 5–0 to approve 14(a)(1) of the CPSA is known as a verification obligations on publication of this proposed rule. Chairman Inez General Conformity Certification (GCC). manufacturers because the Commission Tenenbaum and Commissioners Nancy Nord and Section 14(a)(2) of the CPSA (15 intends to conduct the verification itself Anne Northup filed statements concerning this U.S.C. 2063(a)(2)) establishes testing under its inherent authorities while it action. These statements may be viewed on the Commission’s Web site at http://www.cpsc.gov/pr/ requirements for children’s products gains more experience with the testing statements.html or obtained from the Commission’s that are subject to a children’s product and certification requirements. When Office of the Secretary. safety rule. (Section 3(a)(2) of the CPSA the Commission finds that a children’s

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product accompanied by a certificate of participate in the meeting. Commission required certificate for children’s conformity does not pass the tests upon staff made presentations on specific products can be based on component which the certification was based, it topics and held breakout sessions on: part testing as described in proposed 16 may initiate an investigation of the • Sampling and statistical CFR part 1109, rather than testing of the manufacturer, third party conformity considerations; finished product, if components are assessment body, and any other relevant • Verification of third party test tested by a third party testing party in the supply chain, to determine results; conformity assessment body. the cause of the discrepancy. • Reasonable test programs and third Furthermore, these proposed rules The proposed rule would implement party testing; would allow importers to base their sections 14(a) and (d) of the CPSA, as • Challenges for small manufacturer/ product certification for a children’s amended by section 102(b) of the low-volume production; product on a certificate provided by a CPSIA, by: • Component testing and material foreign manufacturer as long as that • Defining the elements of a changes; and manufacturer has based its certificate on ‘‘reasonable testing program’’ for • Protection against undue influence. third party testing conducted by a third purposes of section 14(a)(1)(A) of the The notice also stated that the party conformity assessment body. CPSA; Commission wanted to use the • B. Responses to Comments on the Establishing the protocols and workshop to discuss possible options Notice of Availability and the Public standards for continuing testing of for implementing section 14 of the Workshop children’s products under section CPSA. Several hundred individuals 14(d)(2)(B)(i), (ii), and (iv) of the CPSA; attended the workshop. In connection with the public and workshop, the Commission invited • Describing the label that The Commission understands the economic ramifications that small public comment on its implementation manufacturers may place on a consumer of various aspects of section 14 of the product to show that the product businesses (and even large businesses) face regarding the testing costs required CPSA. complies with the certification The Federal Register notice requirements for purposes of section by section 102 of the CPSIA. Moreover, retailers and importers may be imposing announcing the meeting identified 14(d)(2)(A) of the CPSA. specific issues for public comment; for The proposed rule also builds upon significant additional testing cost on example, in the section titled, ‘‘What are previous documents and activities by manufacturers by requiring that the issues regarding additional third the Commission. For example, on products that have already been tested party testing of children’s products?’’ the November 3, 2009, Commission staff by a third party conformity assessment Commission asked: made available a draft guidance body be tested again by a specific third • Should the potential hazard (either document titled, ‘‘Guidance Document: party conformity assessment body the severity or the probability of Testing and Certification Requirements selected by the retailer or importer. The occurrence) be considered in Under the Consumer Product Safety Commission wants to emphasize to determining how frequently the Improvement Act of 2008.’’ The draft retailers and sellers of children’s periodic testing is conducted? For guidance document, which is available products that they can rely on at http://www.cpsc.gov/library/foia/ certificates provided by product example, should a product subject to a foia10/brief/102testing.pdf, was suppliers if those certificates are based consumer product safety rule, where the intended to provide the Commission’s on testing conducted by a third party potential hazard is death, be tested more interpretation of the requirements of conformity assessment body. Section frequently than a product where the section 102 of the CPSIA. Specifically, 19(b) of the CPSA provides that a potential hazard is some lesser degree of it sought to describe the Commission’s retailer or seller of a children’s product harm? If so, how might a rule position on a reasonable testing program shall not be subject to civil or criminal incorporate potential hazard into testing frequency? and how to certify that a product penalties for selling products that do not • complies with all rules, bans, standards, comply with applicable safety standards What changes should constitute a or other regulations applicable to the if it holds a certificate issued in ‘‘material change’’ in a product’s design product under the laws enforced by the accordance with section 14(a) of the or manufacturing process? Are there Commission. The guidance document CPSA to the effect that such consumer criteria by which one might determine also sought to explain when and how product conforms to all applicable whether a change is a ‘‘material’’ change? component testing to certain specific consumer product safety rules, unless For example, a material change in a requirements would be allowed. such person knows that such consumer product’s design or manufacturing Although the Commission never voted product does not conform. The process could be described as a change on whether to approve or to not approve Commission notes that section 19(b) of that affects the product’s ability to the issuance of the draft guidance the CPSA does not relieve any person of comply with a consumer product safety document, the draft did represent the the obligation to conduct a corrective rule. However, as a practical matter, it Commission staff’s thinking on the action should any product violate an may be difficult to determine what subject. Shortly thereafter, in the applicable safety standard and need to consumer product safety rules apply to Federal Register of November 13, 2009 be recalled. the product and the extent to which (74 FR 58611), the Commission In order to provide some relief from compliance with those rules is affected announced that it would hold a two-day testing costs, elsewhere in this issue of by a change. public workshop to discuss issues the Federal Register, the Commission See 74 FR at 58614. relating to the testing, certification, and has issued a separate proposed rule The Commission received 38 labeling of consumer products pursuant which would allow for testing of comments, and we discuss those to section 14 of the CPSA. The component parts as a basis for comments, and our responses, in parts workshop was held on December 10 certification of finished products in B.1 through B.12 of this document. To through 11, 2009, in Bethesda, certain circumstances. The Commission make it easier to identify comments and Maryland, and the Commission invited intends to make clear in the two our responses, the word ‘‘Comment’’ or interested parties to attend and proposed rules that, in some cases, the ‘‘Comments’’ will appear before the

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comment’s description, and the word involve less than the five elements certification bodies use to assess ‘‘Response’’ will appear before our outlined by CPSC in the notice for a continuing compliance. response. reasonable testing program. For One comment said that the example, because some regulations 1. The Reasonable Testing Program Commission must issue regulations require placement of a label, the clarifying what will constitute In the Federal Register notice comment said that ‘‘testing’’ in that ‘‘unacceptable or failing’’ test results for announcing the public workshop, the circumstance would consist of product testing. Additionally, the Commission had described a observing that the label was placed comment stated that the Commission’s ‘‘reasonable testing program’’ as properly. regulations should explicitly allow for consisting of: One comment stated that any testing • retesting prior to remanufacturing or Product specifications that describe program that results in an acceptable redesigning. One comment specifically the consumer product and list the safety confidence level that a product stated that the reasonable testing rules, standards, etc., with which the complies with the applicable standards program should be implemented for product must comply. The product should be considered an acceptable children’s products. specification should include a complete reasonable testing program. The Response: The Commission believes description of the product and any other comment also suggested that other that the five elements of a reasonable information, including, but not limited items, such as factory certification (to testing program are adaptable to to, a bill of materials, parts listing, raw recognized standards), audits, risk manufacturers’ and importers’ material selection and sourcing, and/or assessment plans, certification of a circumstances, are present in most model names or numbers of items manufacturer’s quality system, etc., testing programs (even if some of the necessary to describe the product and should be allowed as elements of a elements might seem trivial), and can be differentiate it from other products; reasonable testing plan. accomplished with seemingly little • Certification tests which are One comment suggested allowing effort. However, the five elements are performed on samples of the process capability testing, where, for a essential and should be included to manufacturer’s consumer product to continuous-flow process, first-run ensure a high degree of assurance of demonstrate that the product is capable samples are tested, as a form of compliance to the applicable rules, of passing the tests prescribed by the certification testing. The comment urged bans, standards, or regulations. standard; the Commission to allow a manufacturer • A production testing plan which to search ‘‘backwards’’ and ‘‘forwards’’ in For the product specification describes the tests that must be continuous-flow process for good component of a reasonable testing performed and the testing intervals to product in the event that a test during program, a manufacturer is not required provide reasonable assurance that the manufacturing shows noncompliance. to specify every component or raw products as produced meet all Several comments noted that, for material of a product. The manufacturer applicable safety rules; seasonal or short-run products, only is free to describe its product by model • A remedial action plan which must prototype samples may exist before number, general description, be employed whenever samples of the production begins. Some comments photograph, etc., as long as the product consumer product or results from any stated that neither the same materials is identifiable and differentiable from other tests used to assess compliance nor the same manufacturing processes other products. yield unacceptable or failing test results; were used to manufacture the prototype The Commission agrees that other and samples as would be used to elements such as risk assessment plans, • Documentation of the reasonable manufacture the consumer product. quality system certification, and factory testing program and how it was Multiple comments stated that the certifications could be added to provide implemented. relative hazard should be a factor in a manufacturer with a high degree of See 74 FR at 58613. determining the test frequency. Some assurance that the product produced Comments: Most comments addressed stated that higher risks should complies with all applicable the five elements of the reasonable necessitate a higher test frequency, and requirements. However, many methods testing program, either by suggesting where the perceived risk is low, third suggested in the comments would that the Commission allow for some party testing should not be mandatory require CPSC to assess and recognize or flexibility as to what constitutes a for some products. certify the certification services reasonable testing program or by One comment suggested that a providers and require the manufacturer suggesting specific exceptions or tests as manufacturer’s record of manufacturing and importer to purchase these part of a reasonable testing program. products with low-lead levels should certification services. The approach in Several comments expressed concern result in relaxed testing requirements. the proposed rule seeks to identify a that many manufacturers may not be One comment remarked on the method whereby a manufacturer or able to specify their products down to differences between conformity importer can independently establish a the component or raw material level assessment and certification. The reasonable testing program and establish because proprietary information from comment suggested that CPSC a set of minimum requirements for these offshore manufacturers may prevent regulations should clarify that a reasonable testing programs that reflect importers from knowing every ‘‘reasonable testing program’’ means a commonly used elements of a quality component of the products they conformity assessment process such as assurance/quality control system. If purchase. One comment noted that that in Annex A of ISO/IEC 17000 and process capability testing can ensure importers typically do not control the describe the five elements in generic with a high degree of assurance that the production process of the products they terms that avoid the implication that product is capable of meeting the import, so the Commission should ‘‘testing’’ will always be the evaluation applicable rules, bans, standards, or define a reasonable testing program activity. This comment noted that the regulations, that form of testing can be differently to address an importer’s phrase ‘‘production testing plan’’ is used for certification testing. Similarly, special circumstances. misleading in that only testing is techniques used during production to Another comment suggested that anticipated, and would expand the ensure, with a high degree of assurance, ‘‘reasonable’’ for some products would interpretation to include activities that the continuing production is

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compliant can be considered as program mentioned in section 14(a) of the testing requirements in existing acceptable production testing plans. the CPSA. However, the certification product safety standards to be For children’s products, section testing and the production testing plan acceptable in meeting the requirements 14(a)(2) of the CPSA requires in the reasonable testing program do of section 14 the CPSA, including manufacturers to submit ‘‘sufficient allow a wide latitude of actions in existing regulations with their own samples of the children’s product, or determining initial and continuing reasonable testing program samples that are identical in all material compliance to the applicable rules for a requirements. One comment noted that, respects to the product,’’ to a third party product. unless the Commission can show that conformity assessment bodies for Test results that indicate current industry testing programs are testing. A prototype manufactured with noncompliance to the applicable rules insufficient, no prescribed reasonable different materials or manufacturing are unacceptable or failing test results. testing program should be implemented. processes than the finished product Retesting, as a general matter, should One comment stated that CPSC should cannot be considered the same in all not be allowed because doing so may establish a safe harbor enforcement material respects as the finished product tempt unscrupulous parties to attempt policy regarding recognized programs. with respect to compliance. Therefore, to ‘‘test the product into compliance,’’ The comment noted that an enforcement section 14(a)(2) of the CPSA does not (i.e., to repeat testing a product until a policy that accepts participation in such allow for testing of prototype samples sample passes the test and then reject programs as demonstrable good faith, unless they are identical in all material the earlier unacceptable or failing test without imposition of civil or criminal respects to the finished product. The results). The intent of section 14 of the liability under CPSIA’s expanded proposed rule would extend the CPSA is to conduct tests to provide penalty limits, could act to promote requirement to test only prototype assurance that all the products being participation in effective certification samples that are identical in all material imported, warehoused, or distributed in programs. respects to the finished product that interstate commerce comply with all Response: Manufacturers will need to will be imported for consumption, applicable rules. ensure that any reasonable testing warehoused, or distributed in commerce 2. Flexibility in Testing programs, whether they are industry- to manufacturers of nonchildren’s specific programs or not, also conform products under section 14(a)(1) of the Comments: Many comments stressed the need for flexibility in test protocols. to the requirements of the CPSA and CPSA. any implementing regulations While the Commission agrees that a Some comments stated that the types of promulgated by the Commission. If, in higher risk level should necessitate a products are so varied that no one a manufacturer’s determination, a greater testing frequency, it should be prescribed system could be devised to prescribed testing program ensures with noted that risk and potential severity are effectively and efficiently apply to all of not indicators of the level of compliance them. Other comments noted that a high degree of assurance that the to the legal standards, regulations, rules, determining the number of samples to products distributed in commerce will and bans. Section 14 of the CPSA does be tested should be left to the comply with the applicable rules, then not allow for the exclusion of any manufacturer, who has intimate the manufacturer is free to choose that children’s product from third party knowledge of the product’s program for its product. CPSC cannot testing based on a perceived low level manufacturing process, to decide. generally consider all preexisting testing of risk. Thus, regardless of other existing Response: The Commission agrees regulations to be acceptable for means of determining compliance, that it is difficult to develop rigid purposes of complying with section 14 products must be tested for compliance protocols for testing across all categories of the CPSA. For example, preexisting to the applicable rules, bans, standards, of products, manufacturers, and CPSC regulations may not mandate or regulations. importers. A manufacturer may tailor third party conformity assessment body As for the conformity assessment the tests to the needs of the individual testing for children’s products because process in ISO/IEC 17000, the product, and the tests do not need to be those preexisting CPSC regulations were Commission does not consider it to be the same tests that are specified in the promulgated before the CPSIA’s equivalent to a reasonable testing applicable rules, provided that they are enactment. Further, nothing in section program. In sections 14(a) and at least as effective in assessing 14(a)(1) or 14(b) of the CPSA, nor 14(d)(2)(B) of the CPSA, testing is compliance. The proposed rule would section 3 of the CPSIA, which gives the specifically mentioned as the evaluation leave decisions on procedures, such as Commission the authority to issue activity. Thus, regardless of other means the number of samples to test, up to the regulations to implement the CPSIA, of determining compliance, products manufacturer provided that the testing requires the Commission to find must be tested for compliance to the plan provides a high degree of assurance industry testing programs to be applicable rules. The conformity that noncompliant products are not insufficient before implementing a assessment process mentioned in Annex introduced into the stream of commerce. reasonable testing program. A of ISO/IEC 17000 includes The proposed rule would not include attestations in its principles of 3. Existing Testing Programs any provision for a ‘‘safe harbor’’ conformity assessment. However, the Comments: One comment asked if the enforcement policy based on a CPSA requires the manufacturer to Toy Safety Certification Program manufacturer’s participation in a perform the attestation that its products initiated by the Toy Institute of America voluntary or industry-sponsored comply with the applicable rules. If the (TIA) could be accepted as a reasonable program, nor has the Commission manufacturer uses a third party testing program under section 14(a)(1) of recognized any such program as conformity assessment body to conduct the CPSA. Two other comments indicating compliance within the the testing of its products, then the recommended that CPSC recognize the requirements of the proposed rule. determination and attestation functions value of industry-specific certification Section 14 of the CPSA does not contain would be performed by two separate programs prescribing testing methods a ‘‘safe harbor’’ exception nor does it parties. Thus, the conformity for a product category and verifying establish any criteria by which the assessment process in ISO/IEC 17000 is conformance. Another two comments Commission could ‘‘recognize’’ testing not equivalent to the reasonable testing suggested that CPSC should consider programs for purposes of a ‘‘safe harbor.’’

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4. Random Samples not require random sampling unless a Response: While the Commission will In the Federal Register notice manufacturer produces 10,000 units of a provide general guidance on how to announcing the public workshop, the product at which time the product comply with the requirements of the Commission explained that section would be subject to the proposed CPSIA, manufacturers are responsible 14(d)(2)(B)(ii) of the CPSA refers to the periodic testing requirements. for fully understanding their ‘‘testing of random samples to ensure Regardless of how random sampling is manufacturing process and knowing continued compliance’’ and asked defined, section 14(d)(2)(B) of the CPSA how the regulations would apply to (among other things), ‘‘What constitutes requires samples to be tested. The their products. Because there may be a a ‘random’ sample?’’ See 74 FR at 58614. samples must be selected from products disproportionate effect on small-volume At the workshop itself, CPSC staff in production or supply and must be manufacturers relative to large volume manufacturers, the proposed rule would presented a statistically-based rationale tested by a third party conformity not require periodic testing for for selecting random samples. assessment body. Comments: Many comments Products manufactured in a production volumes of less than 10,000 suggested that the word ‘‘random’’ continuous-flow process ultimately units because certification and periodic should not be interpreted by its strict create individual products. If those testing costs are largely independent of manufacturing volume. Certification statistical definition, but should be products are subject to periodic testing, testing and testing after a material adapted to the product type, how it is the requirement for random samples change are still required and may be manufactured, and its intended use. may constrain where in the performed on portions of the finished One comment stated that random manufacturing process periodic testing product or representative samples that should be interpreted to mean free from samples are selected. In general, product are the same with respect to compliance overt selection bias and that it is more tests at a specific frequency are as the finished product. important that a sample be reasonably susceptible to transient events that could affect compliance and would be As for the comment regarding a representative of the population from SBREFA panel, the requirements for a which it is selected. One comment undetected. Random sampling has the capability of detecting such transient SBREFA panel only apply to the suggested that, with the assistance of Environmental Protection Agency and industry, the CPSC should develop events and is thus required to ensure continued compliance of the product. the Occupational Safety and Health guidelines regarding the circumstances Administration (OSHA). and elements to consider when 5. Challenges for Small Manufacturers/ 6. Verification of Third Party determining what constitutes a Low-Volume Production reasonable random sample. One Conformity Assessment Bodies comment mentioned the problems In the Federal Register notice Comments: Several comments associated with random sampling of announcing the public workshop, the suggested that the CPSC, rather than single-unit production and with very Commission asked, ‘‘What provisions (if manufacturers, should perform any small production volumes (less than 10, any) should be made for small verification of third party conformity for example). One comment noted that manufacturers and manufacturers with assessment bodies. Another comment some manufacturing processes are of a low production volumes and why?’’ See proposed that, upon demand by the continuous-flow type, and randomly 74 FR at 58614. The Commission CPSC, the conformity assessment body selecting a sample would be disruptive explained that specifying the frequency be required to produce a copy of the to the production system. Another of periodic testing or the number of mandatory or voluntary standard against comment stated that products that are random samples to be tested may be which the children’s product is being subjected to continuous testing with a inappropriate where the volume of tested, a copy of the test protocol used specified frequency should be exempt children’s products being manufactured for the test procedure, and a copy of the from any additional random testing. is low or where the children’s product test results that can be traced back to the Response: The Random House is one-of-a-kind. specific sample tested. Another Dictionary of the English Language Comments: Several comments were comment noted that variations in defines ‘‘random sampling’’ as ‘‘a method received specific to small manufacturers sample preparation by conformity of selecting a sample from a statistical who may not have the technical, legal, assessment bodies can and do lead to population in such a way that every or financial resources of large-volume differing test results. One comment, possible sample that could be selected manufacturers. One comment stressed noting lab-to-lab variations in test has the same probability of being the need for step-by-step guidance from results for the same product, suggested selected.’’ The Commission believes that the CPSC on how to follow the rules. that CPSC should require third party this is the most appropriate technical Another comment noted that, for very conformity assessment bodies to definition. It also seems more small production volumes (often one or conduct blind correlation studies and appropriate to use a definition where two custom items), testing of a lab audits. Another comment asserted both terms (random and sampling) are representative sample should be that proficiency testing is the only true defined together rather than two allowed to suffice for all items. Two outside independent verification option separate definitions, one of random and comments concurred with the draft for laboratories and should be limited to the second of sampling. More generally, Guidance Policy document text that did chemical tests only. terms such as a ‘‘representative’’ sample, not require periodic testing for Response: The Commission’s limited a ‘‘non-fraudulent’’ sample, or a ‘‘non- production volumes less than 10,000 resources preclude CPSC from directly golden’’ sample, do not have the units or once a year, whichever is less. conducting verification of the numerous underlying statistical attributes One comment suggested that, due to the conformity assessment bodies. As stated necessary to generalize about economic ramifications associated with earlier in part A of this document, at compliance of the untested portion of the development of a reasonable testing this time, the Commission is not the product population from the tested program, the CPSC should convene a proposing any verification obligations samples. Small Business Regulatory Enforcement on manufacturers because the With regard to low-volume Fairness Act (SBREFA) panel for this Commission intends to conduct the production, the proposed rule would rulemaking. verification itself under its inherent

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authorities while it gains more Sections 20 and 21 of the CPSA final rule resulting from this rulemaking experience with the testing and establish monetary and criminal become effective 180 days after its date certification requirements. Additionally, penalties for violations of section 19 of of publication in the Federal Register. the activities and requirements for the CPSA. Interested parties who believe that the accrediting conformity assessment effective date should be longer or 8. Certificates bodies are outside the scope of this shorter should submit a comment to the rulemaking. Comments: One comment urged the proposed rule. The comment should The Commission acknowledges that Commission to recognize the registered include the specific facts on which they variations in sample preparation can certification marks of recognized base their conclusion. lead to some differences in test results. product certification bodies, like those However, these variations should not be accredited under the OSHA NRTL 9. Reliance on Test Results of Others for significant enough to alter the general program for applicable product scopes, Certification Purposes determination of whether a product in lieu of paper certificates of Comments: Two comments noted that complies with the applicable children’s conformity. Another comment asserted a foreign manufacturer may supply the product safety rule. that the CPSC has no jurisdiction to same product to several importers, who As for proficiency testing (by which issue certification regulations except as would then be required to test the same the Commission means testing part of a reasonable labeling rule product. The comments considered conducted by an independent evaluator adopted under section 14 of the CPSA. such testing of the same product by of the competence of a ‘‘body’’ The comment argued that section 14(a) multiple importers to be wasteful and (organization, person, etc.) to perform of the CPSA gives the manufacturer the inefficient. Another comment stated that specific tasks), the Commission option to select its own form and importers of many products will be considers proficiency testing to be one medium to convey certification of overburdened with testing costs, option for domestic manufacturers and compliance with a CPSC standard. whereas manufacturers making one importers to use for verification Finally, the comment contended that product can efficiently test their purposes. However, the requirements section 14 of the CPSA does not products. The comment added that the for verifying that a children’s product authorize the Commission to adopt any importer would still be responsible for complies with the applicable children’s rule prescribing the content of the the product’s certificate, but would use product safety rules are not limited to certificate or method of its distribution. test data furnished by the manufacturer. only chemical tests. Another comment stated that the CPSC Finally, the comment noted that has no jurisdiction to require that a importers have little control over the 7. Protection of Conformity Assessment certificate be on a separate piece of design, manufacturing process, or Bodies Against Undue Influence paper that accompanies the product. sourcing of component parts, but Comments: One comment suggested The comment also suggested that at manufacturers control all those aspects that provisions of ISO/IEC Guide 65 be least 180 days would be needed to of production. Two other comments used to prevent undue influence from comply with any new requirements. asserted that importers should be being exerted over third party testing Response: The Commission does not allowed to base their certificates on test body by a manufacturer or private believe that registered certification reports and results of other entities. labeler. Other comments suggested that marks, by themselves, would provide Another comment proposed that CPSC laboratory certification beyond ISO/IEC the information required for certificates should recognize the vendor’s 17025 is neither productive nor under section 14 of the CPSA. With assumption of liability in making such necessary. Another comment suggested respect to children’s products, third certification and deem that retailers, that the Commission should look to party conformity assessment bodies importers and distributors of product OSHA’s Nationally Recognized Testing only test children’s products for subject to such certification may rely Laboratory (NRTL) program to ensure compliance with the applicable upon it without facing civil or criminal impartiality and prevent conflict of children’s product safety rules. Third liability. interest. One comment stated that CPSC party conformity assessment bodies are One comment asked for clarification should extend existing CPSC fines and not responsible for issuing certificates for importers who rely on foreign penalties that the CPSC can currently under section 14(a)(2) of the CPSA; to manufacturers’ certificates of conformity impose on manufacturers and retailers the contrary, under existing CPSC regarding what level of diligence can to apply to exerting or attempting to regulations, only domestic reasonably and effectively be exercised exert undue influence on third party manufacturers and importers are by the importers. conformity bodies. required to issue certificates (see 16 CFR One comment recommended that ink Response: ISO/IEC Guide 65 and part 1110; see also 73 FR 68328 manufacturers be allowed to group, test OSHA’s NRTL program both deal with (November 18, 2008)). and certify product families for certifying bodies that perform many Regarding the Commission’s component testing because product functions in addition to the testing jurisdiction to issue certification families represent the same core functions performed by third party regulations, the Commission has the formula. The comment asserted that conformity assessment bodies. The ISO/ authority to issue implementing product family certification provides a IEC 17025 certification system appears regulations under section 3 of the reasonable, economically viable, testing to be working as intended. There is no CPSIA, which provides that ‘‘[t]he model for these ink manufacturers. need to implement duplicative or Commission may issue regulations, as Response: While an importer is not additional requirements by requiring necessary, to implement this Act and required to commission testing itself them in this proposed rule. the amendments made by this Act.’’ The and may, in certain cases, use With regard to extending fines, Commission has not required component part test reports from the section 19 the CPSA already addresses certificates to be only in the form of a manufacturer, the importer is fines and penalties. Section 19(a)(4) of separate piece of paper. Certificates can responsible for issuing the certificate for the CPSA prohibits any attempt to be in electronic form. a children’s product (see 16 CFR exercise undue influence on a third As for the effective date of any final 1110.7(a)). The importer also must party conformity assessment body. rule, the Commission intends that any ensure that the proper testing was

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conducted (i.e., a third party conformity twice per year or once every 50,000 they are as effective in discriminating assessment body accredited for the units in any event, whichever occurs compliance and noncompliance as the correct test conducted the testing). The first. With regard to the sample size for tests specified in the standards as part importer is ultimately responsible for periodic testing, the comment suggested of a reasonable testing program. Neither ensuring that its product meets CPSC (at least for toys) using the 12-unit the reasonable testing program for requirements. In those cases in which sample size which has been the nonchildren’s products nor the the importer has little or no control over requirement of the CPSC Engineering certification and periodic tests for the manufacturing process and is Test Manual for many years as a starting children’s products specify values for relying on the manufacturer’s test data, point. A sample size of 18 pieces could sample size or test frequency. the importer should take measures to be required for higher-risk products The Commission recognizes that no understand the manufacturing and such as infant and toddler toys, and a one-size-fits-all testing program will be testing process. An importer needs to lesser sample could be allowed for large, sufficient for all manufacturers. The ensure that all necessary tests are bulky, or expensive products to proposed rule would state that a conducted in an appropriate manner to minimize cost. reasonable testing program is a program ensure, with a high degree of assurance, Many comments asserted that risk that, when structured with appropriate that no noncompliant product is placed should be factored into any testing specifications, measurements, controls, into commerce. In the Commission’s program. A product that poses a higher and test intervals, will provide a high proposed rule on ‘‘Conditions and level of risk should undergo closer degree of assurance that the consumer Requirements for Testing of Component scrutiny. products manufactured under the Parts of Consumer Products’’ (which One comment provided a list of reasonable testing program will comply appears elsewhere in this issue of the activities that would more precisely with all the requirements of the Federal Register), the Commission is define a material change. The list applicable rules. If a high degree of considering additional issues related to included changes in tooling, product assurance is interpreted to be a the reliance of a manufacturer on the materials, assembly method, or the statistical likelihood of not producing test results of others for certification manufacturing facility. noncompliant products, the sample size purposes. Another comment contended that for periodic testing will depend upon As for the comment regarding ink, an once the children’s product has passed the number of samples that need to be ink that has a similar base formula and its certification testing, periodic testing tested to provide that statistical varies only in color could contain some is not required, and that only a material assurance. The number of samples pigments that contain lead while the change would require retesting. could be fewer than 12 or more than 18. same base with different pigments did One comment noted that first-party The Commission agrees that products not. Thus, families of inks cannot be production testing is used extensively to with a higher potential for injury or grouped for compliance testing. control manufacturing and is effective death should undergo greater scrutiny. However, the Commission has in detecting problems that could lead to Because of the many types of previously made a determination that nonconforming products. The comment children’s products and manufacturing CYMK inks do not need to be tested noted that the information can be used processes that will be covered by the since they do not contain lead. See 16 to reduce the number of samples rule, the description of the activities CFR 1500.91. required for periodic testing to one. that would trigger additional third party One comment suggested that, in testing due to material changes needs to 10. Additional Third Party Testing establishing procedures and standards be described in general terms. A more Requirements for Children’s Products for periodic testing of children’s general description gives manufacturers, Comments: One comment remarked products, CPSC should consider the who are experts in their product areas that the Commission should offer potential for lead exposure in order to and are better suited to understand guidance on the adequacy of specific distinguish between products that pose when a change in their product could programs to firms who request it. The a reasonable risk of noncompliance with affect the product’s ability to comply comment also sought clarification on the lead content limits and products with applicable rules, the flexibility to whether a test could be any reasonable, that pose only a theoretical risk of develop testing programs to suit their objective method for evaluating noncompliance. products and manufacturing operations. compliance with a standard. The Response: Several existing CPSC For children’s products, section comment suggested that any attempt to regulations are product-specific, 14(d)(2)(B)(i) of the CPSA says explicitly specify protocols and standards for allowing the Commission to develop that the rule is intended to establish testing children’s products, such as guidance for those particular protocols and standards to ensure that sample size and frequency, should be manufactured goods. However, section children’s products are tested tied to specific standards. The comment 14(a) of the CPSA covers all products ‘‘periodically,’’ as well as when there has also expressed interest in having the subject to a consumer product safety been a material change to the product. Commission provide a clearer definition standard enforced by the Commission. Thus, even if no changes are made to a of reasonable certainty, especially in the In light of that fact, the CPSC cannot children’s product, it must be tested context of specific standards. Finally, provide guidance for every product and periodically. the comment advised against attempting every manufacturing process. For For children’s products with a to establish any numerical standard, children’s products, only a third party reasonable testing program, it may be such as a specified confidence level conformity assessment body accredited possible to show that one periodic test with a specific number of samples to to perform the required tests is allowed sample verifies and validates the test. to test for compliance to the applicable program. However, for children’s Another comment requested that the children’s product safety rules. products without a reasonable testing Commission should provide reasonably The proposed rule would consider program, in order for third party testing specific guidelines with regard to both non-conformity assessment body tests, to provide a high degree of assurance periodic testing frequency and sample such as production tests, process control that the products produced comply with size to be used in such testing. The measurements, or other means of the rule, the Commission believes that comment suggested a period of at least assessing compliance, to be acceptable if testing only a single sample would not

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be acceptable. Other than the exceptions markings or products that would be production date, the compliance for lead that are specified in section 101 destroyed by marking. One comment identifier, and the model number. of the CPSIA and the lead urged CPSC to include the certification One comment said that the electronic determinations regarding certain requirements of section 14(a) of the availability of certificates should satisfy materials or products in 16 CFR CPSA on a label on the product. the ‘‘accompany’’ and ‘‘furnish’’ 1500.91, all children’s products are Response: Section 14(d)(2)(A) of the requirements as opposed to requiring a required to be tested for lead content. CPSA requires the Commission to paper certificate. One comment stated initiate a program by which a 11. Labeling Program that the CPSC cannot require the manufacturer or private labeler may certificate to contain the specific week As stated earlier in part A of this label their products as complying with of manufacture or the particular unit of document, section 14(d)(2)(A) of the the certification requirements. The equipment used to manufacture the CPSA requires the Commission to Commission staff’s suggested text and product. initiate a program by which a format for the label will make it easier One comment argued that the manufacturer or private labeler may for consumers, small businesses, and Commission has no jurisdiction over label a consumer product as complying any other interested party to notice it, architectural glass (e.g., glass used in with the certification requirements. This understand its meaning, and distinguish windows and doors). provision applies to all consumer it from tracking labels. Varying the text Response: Because these comments products that are subject to a product and the font size and style on the label address issues that are unrelated to safety rule administered by the could lead to greater confusion in reasonable testing programs, continued Commission. understanding than a consistent label. testing of children’s products, and labels Comments: One comment Because the use of the label is optional to show that a product complies with recommended that the Commission not for manufacturers, similar-looking the certification requirements in section initiate a labeling program because it products, or even units of the same 14(a) of the CPSA, they are outside the will contribute to confusion within the product, may or may not contain the scope of this rule. Consequently, we small business community about the label. The label is intended to show decline to address them here. tracking label. Another comment compliance with CPSC certification suggested that the Commission should requirements. It is not intended to be a C. Description of the Proposed Rule provide examples of allowable text for tracking label or demonstrate The proposal would create a new part such labels, but should not have specific compliance with laws or regulations in Title 16 of the Code of Federal requirements for things such as size, administered by other federal agencies. Regulations: Part 1107, titled ‘‘Testing color, font or location as these will The comment suggesting the and Labeling Pertaining to Product depend on the product. The comment Commission should include the Certification.’’ The new part 1107 would further noted that it would be a huge certification requirements of section consist of four subparts: Subpart A burden to impose specifications such as 14(a) of the CPSA on a label on the would be ‘‘General Provisions’’; Subpart ‘‘label’’ text or size. product is outside the scope of the One comment noted that some B would be the requirements for a labeling program in the proposed rule ‘‘ children’s products currently must Reasonable Testing Program for which is being promulgated pursuant to ’’ contain a label and that label should be Nonchildren’s Products ; Subpart C section 14(d)(2)(A) of the CPSA. would be the requirements for considered sufficient. Two comments Additionally, on November 18, 2008, stated that, if a consumer compares a ‘‘Certification of Children’s Products’’; the Commission issued a rule (see 16 and Subpart D would be the children’s product with a label stating CFR part 1110; see also 73 FR 68328) compliance to all applicable rules to a requirements for a ‘‘Consumer Product addressing the requirements for Labeling Program.’’ comparable product with no applicable certificates under section 14(a) of the rules (and thus no label), the absence of CPSA. 1. Proposed Subpart A General the label will be misperceived as Provisions noncompliance by the consumer and 12. Comments Outside the Scope of the will thus disadvantage the second Rule a. Proposed § 1107.1—Purpose product. One comment suggested that Comments: Several comments Proposed § 1107.1 would state that the label requirement be harmonized as addressed issues pertaining to specific part 1107 establishes the requirements best as possible with existing Federal tests or other provisions in the CPSIA, for: a reasonable testing program for regulations such as U.S. Customs and such as tracking labels and the nonchildren’s products; third party Border Production country of origin interpretation of statutory definitions. conformity assessment body testing to labeling (19 U.S.C. 1304 and 19 CFR Several comments suggested that x- support certification and continuing 134.33) and the Federal Trade ray fluorescence (XRF) technology testing of children’s products; and Commission’s Textile and Wool should be an acceptable method to test labeling of consumer products to Products Identification Act’s fiber for the presence of lead. indicate that the certification content labeling requirements (15 U.S.C. Two comments suggested that CPSC requirements have been met pursuant to 70 and 16 CFR part 303). Another require a hazard analysis of children’s sections 14(a)(1), and (a)(2), (d)(2)(B) of comment said that the use of the label products if manufacturers are permitted the CPSA (15 U.S.C. 2063(a)(1), (a)(2), should be restricted to identifying the to perform the analysis themselves (d)(2)(B)). manufacturer/importer and the batch to without a third party check of the b. Proposed § 1107.2—Definitions help facilitate and narrow the scope of results. recalls. One comment suggested that One comment would interpret the Proposed § 1107.2 would state that, there needs to be accommodations or CPSIA’s definition of ‘‘children’s unless otherwise stated, the definitions exclusions for products that are product’’ as a product with which a of the Consumer Product Safety Act and impossible to mark that are similar to child plays. the Consumer Product Safety exclusions provided in the J list of the One comment suggested that the Improvement Act of 2008 apply to this U.S. Customs and Border Protection CPSC tracking label require the name of part. Proposed § 1107.2 also would regulations for country of origin the manufacturer or importer, the define certain terms or abbreviations for

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purposes of part 1107. For example, we recognize that defining a ‘‘high certification continue to meet all the with respect to abbreviations, proposed degree of assurance’’ as a 95 percent or applicable safety rules. § 1107.2 would define ‘‘CPSA’’ to mean greater probability could result in Proposed § 1107.2 would define ‘‘third the Consumer Product Safety Act. greater testing demands on small party conformity assessment body’’ to Proposed § 1107.2 would define ‘‘CPSC’’ manufacturers. For example, for a non- mean a third party conformity to mean the Consumer Product Safety quantitative test, a method such as the assessment body recognized by the Commission. ‘‘rule of three’’ could be used to CPSC to conduct certification testing on Proposed § 1107.2 would define determine the number of samples children’s products. ‘‘detailed bill of materials’’ to mean a list needed for testing. For a 95 percent 2. Proposed Subpart B—Reasonable of the raw materials, sub-assemblies, confidence that no more than five Testing Program for Nonchildren’s intermediate assemblies, sub- percent of the production fails to Products component parts, component parts, and comply, 3/0.05 = 60 units will be the quantities of each needed to needed for testing. For small production Proposed subpart B would consist of manufacture a finished product. volumes where 60 samples would be one provision and would describe the Proposed § 1107.2 would define ‘‘due considered excessive, alternative ‘‘reasonable testing program’’ for care’’ to mean the degree of care that a methods would be needed. Thus, we nonchildren’s products. prudent and competent person engaged decided against defining ‘‘high degree of a. Proposed § 1107.10—Reasonable in the same line of business or endeavor assurance’’ with respect to a 95 percent Testing Program for Nonchildren’s would exercise under similar probability or confidence level because Products circumstances. there may be difficulty in applying the Proposed § 1107.2 would define ‘‘high statistical methods to all manufacturing Proposed § 1107.10(a) would state degree of assurance’’ to mean an processes. We invite comment on that, except as otherwise provided in a evidence-based demonstration of possible amendments or revisions to the specific regulation under this title or a consistent performance of a product proposed definition of ‘‘high degree of specific standard prescribed by law, a regarding compliance based on assurance.’’ manufacturer certifying a product knowledge of a product and its Proposed § 1107.2 would define pursuant to a reasonable testing program manufacture. The term ‘‘high degree of ‘‘identical in all material respects’’ to must ensure that the reasonable testing assurance’’ appears in several proposed mean there is no difference with respect program provides a high degree of provisions, and so the concept of what to compliance to the applicable rules assurance that the consumer products constitutes a ‘‘high degree of assurance’’ between the samples and the finished covered by the program will comply would be important for purposes of product. with all applicable rules, bans, interpreting and complying with certain Proposed § 1107.2 would define standards or regulations. The proposed proposed sections. We considered ‘‘manufacturer’’ to mean the parties exception for specific regulations or several alternative definitions for a high responsible for certification of a standards prescribed by law is meant to degree of assurance. One alternative consumer product pursuant to 16 CFR recognize that certain preexisting CPSC definition would be, for quantitative part 1110. Currently, 16 CFR part 1110 regulations or standards that were tests, where a high degree of assurance limits the certification requirement to previously voluntary standards which, would be at least a 95 percent domestic manufacturers and importers. by statute, are now considered to be probability that all the product Proposed § 1107.2 would define mandatory consumer product safety produced meets the requirements of the ‘‘manufacturing process’’ to mean the standards or are to be adopted as applicable rules; for non-quantitative techniques, fixtures, tools, materials, mandatory standards may have specific (pass/fail) tests, a high degree of and personnel used to create the testing requirements or protocols. The assurance could mean a 95 percent component parts and assemble a reasonable testing programs confidence that at least 95 percent of the finished product. requirements under proposed § 1107.10 product produced meets the Proposed § 1107.2 would define are not intended to supersede those requirements of the applicable rules. ‘‘production testing plan’’ to mean a preexisting testing requirements listed The 95 percent level is widely used in document that shows what tests must be in Table 1. Table 1 only lists testing the natural and social sciences as the performed and the frequency at which requirements as they pertain to minimum acceptable probability for those tests must be performed to nonchildren’s products because determining statistical significance and provide a high degree of assurance that proposed § 1107.10 would not apply to has been found to be effective. However, the products manufactured after children’s products.

TABLE 1—EXISTING TESTING PROGRAMS THAT WOULD NOT BE SUPERSEDED BY PROPOSED § 1107.10 REGARDING A REASONABLE TESTING PROGRAM

16 CFR part Subject

1201 ...... Safety Standard for Architectural Glazing Materials. 1202 ...... Safety Standard for Matchbooks. 1203 ...... Safety Standard for Bicycle Helmets. 1204 ...... Safety Standard for Omnidirectional Citizen Band Base Station Antennas. 1205 ...... Safety Standard for Walk-Behind Power Lawn Mowers. 1207 ...... Safety Standard for Swimming Pool Slides. 1209 ...... Interim Safety Standard for Cellulose Insulation. 1210 ...... Safety Standard for Cigarette Lighters. 1211 ...... Safety Standard for Automatic Residential Garage Door Operators. 1212 ...... Safety Standard for Multi-Purpose Lighters. 1610 ...... Standard for the Flammability of Clothing Textiles. 1611 ...... Standard for the Flammability of Vinyl Plastic Film.

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TABLE 1—EXISTING TESTING PROGRAMS THAT WOULD NOT BE SUPERSEDED BY PROPOSED § 1107.10 REGARDING A REASONABLE TESTING PROGRAM—Continued

16 CFR part Subject

1630, 1631 ...... Standards for the Surface Flammability of Carpets and Rugs.

A reasonable testing program serves a reasonable testing program would be product listed on a general conformity as the basis for issuance of the general necessary to demonstrate a product’s certification in sufficient detail to conformity certification for compliance at the time of certification identify the product and distinguish it nonchildren’s products unless the and as production of the product from other products made by the manufacturer conducts a test of each continues after certification. Because the manufacturer. Proposed § 1107.10(b)(1) product. A reasonable testing program is requirement for a reasonable testing would state that the product a program that, when structured with program would apply to a wide variety specification may include items such as appropriate specifications, of product types and manufacturing a color photograph or illustration, measurements, controls, and test processes, it is designed to be scalable model names or numbers, a detailed bill intervals, will provide a high degree of to production volumes and adaptable to of materials, a parts listing, raw material assurance that the consumer products the specifics of the product. A selection and sourcing requirements. manufactured under the reasonable manufacturer may develop the scope Proposed § 1107.10(b)(1)(i) would state testing program will comply with all the and details of each element of a that a product specification must requirements of the applicable rules. reasonable testing program based on the include any component parts that are The manufacturer is responsible for manufacturer’s knowledge and expertise certified pursuant to 16 CFR part 1109. establishing a reasonable testing regarding the product and its (Elsewhere in this issue of the Federal program because it is necessary to manufacturing processes. Register, the Commission is issuing a support the issuance of a general The Commission’s primary concern is proposed rule regarding component part conformity certificate where a test of ensuring that manufacturers produce testing.) each product is not undertaken. All the safe and compliant products. Testing is Proposed § 1107.10(b)(1)(ii) would elements of the reasonable testing not an end in itself, but rather one part state that product specifications that program should be in place, and of a process to ensure the safety of identify individual features of a product certification tests completed with consumer products. For this reason, the that would not be considered a material passing results before a general Commission believes the primary change may use the same product conformity certificate can be issued for objective in a reasonable testing specification for all products a product. program is determining whether or not manufactured with those specific Several existing nonchildren’s a manufacturer produces safe and features. Features that would not be product standards issued by the compliant products. When CPSC staff considered a material change include Commission already contain product- discovers unsafe or noncompliant different product sizes or other features specific testing programs that were products, CPSC may have reason to that cover variations of the product developed by the Commission at the examine a manufacturer’s programs and where those variations do not affect the time the standard was issued and for processes. Because the Commission which certification was required before recognizes that even the best processes product’s ability to comply with the CPSIA’s enactment. For existing can occasionally yield noncompliant applicable rules. For example, several rules that contain testing requirements, products, the Commission is especially sizes of the same article of clothing and do not contain specific testing concerned about unsafe or made with the same materials would programs, the reasonable testing noncompliant products emerging from not be considered a material change. program establishes the minimum set of defective processes. Another example would be if a product requirements to be met for certification. Proposed § 1107.10(b) would describe specification lists a number of For the remaining applicable rules, the the five elements that a reasonable complying component parts that are implementation of reasonable testing testing program must contain. The grouped in a number of different programs will vary depending on the Commission invites comments on these combinations for separate products, the product under consideration and the five elements of a reasonable testing differences in the number of component compliance characteristics being tested. program. How well do these elements parts between the products would not Persons issuing general conformity fall within the elements of existing be considered a material change. certificates should exercise due care in quality assurance/quality control Additionally, a product with different developing and implementing a programs? In cases where no quality versions of software downloaded into reasonable testing program that assurance/quality control programs various units that would not affect demonstrates that their products comply exist, what activities will have to occur compliance, such as various language with the applicable rules. to implement the proposed reasonable packages downloaded into various Commission staff examined existing testing program? Please explain. educational toys, would not be CPSC regulations, such as the Proposed § 1107.10(b)(1) would state considered a material change. regulations pertaining to that a reasonable testing program must Proposed § 1107.10(b)(1)(iii) would omnidirectional citizens band base have a product specification. The state that each manufacturing site must station antennas, walk-behind lawn product specification would contain a have a separate product specification. mowers, and automatic residential description of the consumer product This would be required because a garage door openers, and selected and lists the applicable rules, bans, manufacturer cannot assume that units common features of existing reasonable standards or regulations to which the of the same product manufactured in testing programs that CPSC has found to product is subject. A product more than one location are identical in be effective. The proposed elements of specification should describe the all material respects.

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Proposed § 1107.10(b)(2) would state bans, standards, or regulations. if they are not the tests prescribed in the that a manufacturer must conduct Proposed § 1107.10(b)(2)(ii)(A) would applicable rule, ban, standard, or certification tests on a product before state that when a previously-certified regulation. issuing a general conformity certificate product undergoes a material change • A separate production testing plan for that product. Certification tests that only affects the product’s ability to for each manufacturing site; and provide evidence that a product comply with certain applicable rules, • Production testing intervals identified in a product specification bans, standards, or regulations, selected to be short enough to ensure complies with the applicable rules, certification for the new product that, if the samples selected for bans, standards, or regulations. specification may be based on production testing comply with an Certification tests are required as part of certification testing of the materially applicable rule, ban, standard, or a reasonable testing program in lieu of changed component part, material, or regulation, there is a high degree of a test of each product. Proposed process, and the passing certification assurance that the untested products § 1107.10(b)(2) would state that a tests of the portion of the previously- manufactured during that interval also certification test would be a test certified product that were not will comply with the applicable rule, performed on samples of the product materially changed. For example, if a ban standard, or regulation. Production that are identical to the finished product material change is limited to using a test intervals should be appropriate for in all material respects to demonstrate different paint on the product, new the specific testing or alternative that the product complies with the certification testing of that product may measurements being conducted. applicable safety rules. Proposed be limited to evaluating the paint to the Proposed § 1107.10(b)(3)(iii)(A) would § 1107.10(b)(2) would require applicable safety rules. allow a manufacturer to use certification tests to contain certain Proposed § 1107.10(b)(2)(ii)(B) would measurement techniques that are elements. require a manufacturer to conduct a nondestructive and tailored to the needs Proposed § 1107.10(b)(2)(i) would certification test of the finished product of an individual product instead of state that, for purposes of proposed if a material change affects the finished conducting product performance tests to § 1107.10, a sample means a component product’s ability to comply with an assure a product complies with all part of the product or the finished applicable rule, ban, standard, or applicable rules, bans, standards, or product which is subjected to testing. regulation. Proposed regulations. For example, a Samples submitted for certification § 1107.10(b)(2)(ii)(C) would require a manufacturer may have determined testing would be required to be identical manufacturer to exercise due care to that, by controlling the particle size and in all material respects to the product to ensure that reliance on anything other water content of cellulose insulation, it be distributed in commerce. The than retesting of the finished product is possible to determine compliance to manufacturer would be required to after a material change occurs does not the cellulose insulation critical radiant submit a sufficient number of samples allow a noncompliant product to be flux test (16 CFR part 1209.6) by for certification testing so as to provide distributed in commerce. A examination of a sample of a fixed a high degree of assurance that the manufacturer should resolve any doubts volume under a graduated microscope certification tests accurately represent in favor of retesting the finished product and measuring its weight. Sizes and the product’s compliance with all for certification. weights within certain limits mean that applicable rules. Proposed § 1107.10(b)(3) would the insulation will pass the critical Proposed § 1107.10(b)(2)(i)(A) would explain that a production testing plan radiant flux test. As another example, a only allow finished products or describes what tests must be performed manufacturer may choose to determine component parts listed on the product and the frequency at which those tests compliance to the requirements for specification to be submitted for must be performed to provide a high garage door opener photoelectric certification testing. Proposed degree of assurance that the products sensors (16 CFR 1211.11) by placing the § 1107.10(b)(2)(i)(B) would allow a manufactured after certification sensor in a fixture with a calibrated light manufacturer to substitute component continue to meet all the applicable flux, then measuring the response part testing for finished product testing safety rules, bans, standards, or voltage of the light-sensitive element pursuant to 16 CFR part 1109 unless the regulations. A production testing plan directly. An element output voltage rule, ban, standard or regulation may include recurring testing or the use above a threshold would indicate applicable to the product requires of process management techniques, passing performance for the tests testing of the finished product. If a such as control charts, statistical process described in the safety standard. manufacturer relies upon certification control programs, or failure modes and Proposed § 1107.10(b)(3)(iii)(B) would testing of component part(s) (rather than effects analyses (FMEAs), designed to require any production test method tests of the finished product), the control potential variations in product used to conduct production testing to be manufacturer would be required to manufacturing that could affect the as effective in detecting noncompliant demonstrate how the combination of product’s ability to comply with the products as the tests used for testing of component part(s), portions of applicable rules, bans, standards, or certification. Proposed the finished product, and finished regulations. § 1107.10(b)(3)(iii)(C) would state that if product samples demonstrate, with a Proposed § 1107.10(b)(3)(i) through a manufacturer is uncertain whether a high degree of assurance, compliance (iii) would require a production test production test is as effective as the with all applicable rules, bans, plan to contain the following elements: certification test, the manufacturer must standards, or regulations. • A description of the production use the certification test. For example, if Proposed § 1107.10(b)(2)(ii) would testing plan, including, but not limited the probability that all production state that a material change is any to, a description of the tests to be products are compliant using the tests change in the product’s design, conducted or the measurements to be methods used for certification is 95 manufacturing process, or sourcing of taken, the intervals at which the tests or percent, the probability that all component parts that a manufacturer measurements will be made, the number production products are compliant exercising due care knows, or should of samples tested, and the basis for using alternative testing methods should know, could affect the product’s ability determining that such tests provide a be at least 95 percent. If there is to comply with the applicable rules, high degree of assurance of compliance uncertainty whether the test method

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will achieve the same level of detection Proposed § 1107.10(b)(5)(i)(A) through product that was the subject of that of compliance, then the specific tests (b)(5)(i)(E) would identify the records remedial action and the product required by the applicable rules should that a manufacturer of a nonchildren’s specification of any new product be used. product would be required to maintain. resulting from any remedial action. Proposed § 1107.10(b)(4) would In brief, these records would be: Proposed § 1107.10(b)(5)(ii) would describe the remedial action plan. • Records of the general conformity require a manufacturer to create a new Proposed § 1107.10(b)(4)(i) would state certificate for each product; set of records for a product if a remedial that a remedial action plan describes the • Records of each product action results in a new product steps to be taken whenever samples of specification; specification. a product or a component part of a • Records of each certification test Proposed § 1107.10(b)(5)(iii) would product fails a test or fails to comply and, if the manufacturer elected to have require a manufacturer to maintain the with an applicable rule, ban, standard, a third party conformity assessment records specified in subpart B at the or regulation. A remedial action plan body test the product, identification of location within the United States would be required to contain any third party conformity assessment specified in 16 CFR 1110.11(d) or, if the procedures the manufacturer must body on whose testing the certificate records are not maintained at the follow to investigate and address failing depends. Records of certification tests custodian’s address, at a location within test results in addition to any reporting would be required to describe how the the United States specified by the obligation it may have. Manufacturers product was certified as meeting the custodian. The manufacturer would be would be required to take remedial requirements, including how each required to make these records action after any failing test result to applicable rule was evaluated, the test available, either in hard copy or ensure with a high degree of assurance results, and the actual values of the electronically, for inspection by the that the products manufactured after the tests; CPSC upon request. remedial action has been taken comply • Records to demonstrate compliance Proposed § 1107.10(b)(5)(iv) would with the applicable rules, bans, with the production testing plan require a manufacturer to maintain standards, or regulations. The type of requirement, including a list of the records (except for test records) for as remedial action may differ depending applicable rules, bans, standards, or long as the product is being produced or upon the applicable rule, ban, standard, regulations, a description of the types of imported by the manufacturer plus five or regulation. Proposed production tests conducted, the number years. The proposal also would require § 1107.10(b)(4)(i) also would state that a of samples tested, the production test records to be maintained for five remedial action can include, but is not interval selected for performance of years and all records to be available in limited to, the following: each test, and the test results. Records the English language. Records would be • Changes to the manufacturing of a production test program would be required to be maintained for five years process, the equipment used to required to describe how the production because the statute of limitations under manufacture the product, the product’s tests demonstrate that the continuing 28 U.S.C. 2462 allows the Commission materials, or design; production complies with the to bring an action within that time. It • Reworking the product produced; applicable rules. References to would be unnecessarily burdensome to or techniques in relevant quality require a manufacturer to maintain • Other actions deemed appropriate management and control standards, records beyond the time the by the manufacturer, in the exercise of such as ANSI/ISO/ASQ Q9001–2008: Commission could pursue an action. due care, to assure compliant products. Quality management systems— Proposed § 1107.10(c) would state Proposed § 1107.10(b)(4)(ii) would Requirements, ANSI/ASQ Z1.4–2008: that, if any certification test results in a state that any remedial action that Sampling Procedures and Tables for failure, a manufacturer cannot certify a results in a material change to a Inspection by Attributes, and/or ANSI/ product until the manufacturer has product’s design, parts, suppliers of ASQ Z1.9–2008: Sampling Procedures taken remedial action, and the product parts, or manufacturing process that and Tables for Inspection by Variables manufactured after the remedial action could affect the product’s ability to for Percent Nonconforming, would be passes certification testing. comply with any applicable rules would allowed to demonstrate that the Proposed § 1107.10(d) would state require a new product specification for production tests have the necessary that a manufacturer of a nonchildren’s that product. Before a product covered accuracy, precision sensitivity, product may, but is not required to, use by the new product specification can be repeatability, and confidence to a third party conformity assessment certified as compliant with the distinguish between compliant and body to conduct certification testing. applicable rules, bans, standards, or noncompliant products. These The third party conformity assessment regulations, a manufacturer would be standards are widely recognized in body would not have to be a third party required to have passing certification industry and were developed by conformity assessment body recognized test results for the applicable rules, organizations with international by the CPSC to conduct certification bans, standards, or regulations. exposure and millions of members. testing on children’s products. Proposed § 1107.10(b)(5) would Retaining test results can help identify Proposed § 1107.10(e) would state impose recordkeeping requirements to the events that led to the creation of that manufacturers of children’s document the reasonable testing noncompliant products, the number of products may voluntarily establish a program. Documentation is necessary to products affected, and their disposition; reasonable testing program consistent establish the identity of the product, and with this subpart. and to demonstrate that the product • Records of all remedial actions complies with the applicable rules, taken, including the specific action 3. Proposed Subpart C—Certification of when it is certified and on a continuing taken, the date the action was taken, the Children’s Products basis as production progresses. person who authorized the actions, and Proposed subpart C would contain the Documentation supports the validity of any test failure which necessitated the requirements pertaining to the a general conformity certificate and action. Records of remedial action certification of children’s products. The provides validation that a test of each would be required to relate the action subpart would consist of seven sections, product produced is not necessary. taken to the product specification of the and most sections would implement the

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requirements in section 14(d)(2)(B) of manufacturer wishes to test the sweater testing described above. Other the CPSA. for compliance to the lead limits in circumstances may arise during Some industries have developed and section 101 of the CPSIA. Because the production of the product that may implemented testing and certification Commission has determined that require consideration of additional programs that are intended to determine textiles, such as cotton, do not exceed testing by a third party conformity compliance with specific standards. The the statutory lead limits, the assessment body. The factors described Commission invites comments about manufacturer would test the metal in proposed § 1107.21(c)(2) may provide such programs. zipper only for lead rather than the some guidance in those circumstances. Proposed § 1107.21(a) would a. Proposed § 1107.20—General cotton in the sweater. In this example, implement the periodic testing Requirements therefore, testing the component part (the metal zipper) is sufficient to requirement in section 14(d)(2)(B)(i) of Proposed § 1107.20(a) would require determine the finished product’s the CPSA by requiring each manufacturers to submit a sufficient compliance with the lead limit. manufacturer to conduct periodic number of samples of a children’s Proposed § 1107.20(d) would state testing at least annually, except as product, or samples that are identical in that, if a product sample fails otherwise provided in paragraphs (b) all material respects to the children’s certification testing, even if other and (d) of this section (which we product, to a third party conformity samples have passed the same discuss later in this part of the assessment body for testing to support certification test, the manufacturer must preamble) or as provided in regulations certification. The proposal would not investigate the reasons for the failure under this title. Manufacturers may specify the exact number of samples to and take remedial action. A need to conduct periodic tests more be tested; instead, the proposal would manufacturer would not be allowed to frequently than on an annual basis to require that the number of samples certify the children’s product until the ensure a high degree of assurance that selected provide a high degree of manufacturer establishes, with a high the product being tested complies with assurance that the tests conducted for degree of assurance, that the finished all applicable children’s product safety certification purposes accurately product does comply with all applicable rules. More frequent periodic testing demonstrate the ability of the children’s children’s product safety rules. may help a manufacturer identify product to meet all applicable children’s noncompliant products more quickly b. Proposed § 1107.21 Periodic Testing product safety rules. and, as a result, may limit the scope of Proposed § 1107.20(b) would state Section 14(d)(2)(B)(i) of the CPSA any potential product recall. In that, if the manufacturing process for a requires children’s products to be tested addition, more frequent testing may children’s product consistently creates periodically for compliance with all reduce the manufacturer’s liability for parts that are uniform in composition applicable children’s product safety civil penalties resulting from a and quality, a manufacturer may submit rules. Although the statute does not noncompliant product, reduce potential fewer samples to provide a high degree require all periodic testing to be damage to a manufacturer’s reputation, of assurance that the finished product conducted by a third party conformity and increase the manufacturer’s complies with the applicable children’s assessment body, the Commission confidence in the effectiveness of the product safety rules. If the proposes to require that manufacturers periodic testing. manufacturing process for a children’s submit samples of their products to a Proposed § 1107.21(b) would state product results in variability in the third party conformity assessment body that, if a manufacturer has implemented composition or quality of children’s for testing to the applicable children’s a reasonable testing program as products, a manufacturer may need to product safety rules at least once every described in subpart B of this part (with submit more samples to provide a high two years if they have a reasonable the exception of the certification degree of assurance that the finished testing program. As proposed by the element which, for children’s products, product complies with the applicable Commission, not every periodic test has would be required to comply with the children’s product safety rules. An to be done by a third party conformity requirements in proposed § 1107.20), it example of a manufacturing process that assessment body if the manufacturer has would be required to submit samples of consistently creates highly similar parts implemented four elements of a its product to a third party conformity would be die casting. Manufacturing reasonable testing program as described assessment body for periodic testing to processes with greater inherent in subpart B of this part (certification for all applicable children’s product safety variability may necessitate testing of children’s products is covered by rules at least once every two years. If a more samples to provide a high degree proposed § 1107.20 of this part). manufacturer’s reasonable testing of assurance that the finished product Depending upon the type and rigor of program fails to provide a high degree complies with the applicable children’s the production testing done by a of assurance of compliance with all product safety rules. An example of a manufacturer, and the manufacturer’s applicable children’s product safety manufacturing process with greater ability to do in-house compliance rules, the Commission may require the inherent variability would be hand testing of the product or component part manufacturer to meet the requirements assembly of the product. to the applicable children’s product of proposed § 1107.21(c) or modify its Proposed § 1107.20(c) would state safety rule(s), production testing may reasonable testing program to ensure a that, except where otherwise specified serve as the non-third party periodic high degree of assurance. Currently, the by a children’s product safety rule, a compliance testing. The Commission rule on children’s bicycle helmets is the manufacturer may substitute component recognizes that some compliance testing only children’s product safety rule that part testing for finished product testing may be too complex for a manufacturer contains requirements for a reasonable pursuant to 16 CFR part 1109 if the to undertake in-house. In that case, the testing program. The reasonable testing component part, without the remainder manufacturer may elect to have the program requirements in this rule are of the finished product, is sufficient to product or a component part tested by not intended to replace that preexisting determine compliance for the finished a third party which may or may not be testing requirement. For existing rules product. For example, assume that a a third party conformity assessment that contain testing requirements and do children’s product is a cotton sweater body, depending upon whether the test not contain specific testing programs, with a metal zipper and that the satisfies the schedule for periodic the reasonable testing program and the

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two year minimum third party on the manufacturer’s knowledge of the manufacturer would be subject to the conformity assessment testing product and its manufacturing periodic testing requirements of requirement establishes the minimum processes. Under proposed proposed § 1107.21(a), and (b) or (c). set of requirements for periodic testing. § 1107.21(c)(2)(i) through (c)(2)(ix), The manufacturer is responsible for As the Commission promulgates new or factors to be considered when deciding how often such periodic revised children’s product safety rules, determining the periodic testing interval testing will occur. In other words, it may establish different testing would include, but not be limited to: assume that a manufacturer produces requirements for those children’s • High variability in test results, as 9,000 units of product X. Under the products than the requirements indicated by a relatively large sample proposal, the manufacturer would not described in this proposed rule. standard deviation in quantitative tests; have to engage in periodic testing unless Proposed § 1107.21(c) would state • Measurements that are close to the it produces 10,000 units of product X; that, if a manufacturer has not allowable numerical limit for at that time, the manufacturer would be implemented a reasonable testing quantitative tests; required to conduct periodic testing on program as described in subpart B of • Known manufacturing process an annual basis (under proposed this part, then all periodic testing would factors which could affect compliance § 1107.21(a)) and it would be required to be required to be conducted by a third with a rule. For example, if the comply with the requirements of party conformity assessment body, and manufacturer knows that a casting die proposed § 1107.21(b) or § 1107.21 (c) the manufacturer would be required to wears down as the die nears the end of (depending on whether the conduct periodic testing described in its useful life, the manufacturer may manufacturer has implemented a proposed § 1107.21(c)(1) and (c)(2). In wish to test more often as the casting die reasonable testing program under brief, proposed § 1107.21(c)(1) would wears down; subpart B). The proposal would not require the manufacturer to develop a • Consumer complaints or warranty require the manufacturer to engage in periodic test plan to assure that claims; periodic testing every time it produces children’s products manufactured after • Nonmaterial changes such as 10,000 units of product X. the issuance of a children’s product introduction of a new set of component The low-volume exception would certification, or when the previous parts into the assembly process, or the apply both to manufacturers and periodic testing was conducted, manufacture of a fixed number of importers who produce or import a continue to comply with all applicable products; specific product at a low volume children’s product safety rules. The • Potential for serious injury or death (10,000 units under the proposed rule). periodic test plan would have to include resulting from a noncompliant In other words, proposed § 1107.21(d) the tests to be conducted, the intervals children’s product; would focus on the volume of a specific at which the tests will be conducted, the • The number of children’s products product rather than attempt to number of samples tested, and the basis produced annually, such that a distinguish between ‘‘large’’ and ‘‘small’’ for determining that the periodic testing manufacturer should consider testing a manufacturers. Thus, an individual who plan provides a high degree of assurance children’s product more frequently if hand carves 30 products would fall that the product being tested continues the product is produced in very large within proposed § 1107.21(d), as would to comply with all applicable children’s numbers or distributed widely a multinational corporation who makes product safety rules. The proposal throughout the United States; 9,000 units of a particular product. would require the manufacturer to have • The children’s product’s similarity c. Proposed § 1107.22—Random a separate periodic testing plan for each to other children’s products with which Samples manufacturing site producing a the manufacturer is familiar and/or children’s product. whether the children’s product has Proposed § 1107.22 would implement Proposed § 1107.21(c)(2) would many different component parts the testing of random samples require the periodic testing interval compared to other children’s products requirement in section 14(d)(2)(B)(ii) of selected to be short enough to ensure of a similar type; and the CPSA by requiring each that, if the samples selected for periodic • The inability to determine the manufacturer of a children’s product to testing pass the test, there is a high children’s product’s noncompliance select samples for periodic testing by degree of assurance that the other easily through means such as visual using a process that assigns each sample untested children’s products inspection. in the production population an equal manufactured during the interval Proposed § 1107.21(d) would pertain probability of being selected. We comply with the applicable children’s to the periodic testing frequency for recognize that there are alternative product safety rules. The interval for low-volume manufacturers. In brief, the approaches for deciding whether periodic testing may vary depending proposal would not require a something represents a ‘‘random’’ upon the specific children’s product manufacturer to conduct periodic sample. One alternative approach would safety rules that apply to the children’s testing unless it has produced or be to say that a random sample is a product. For example, the intervals imported more than 10,000 units of a sample not intentionally identified selected to test for small parts where particular product. (See Appendix A of beforehand for testing. Another possible there is variability in the factors the Memorandum Requirements for approach would be to require only that assuring that no small parts are created, Certification and Continued Testing of a random sample adequately represent and for lead in paint, where one tested Children’s Products, Established by the the production sample pool from which container is used for a large production Consumer Product Safety Improvement it was chosen. The Commission chose volume, may not be the same. Assuring Act of 2008 from Randy Butturini, neither alternative because the purpose that products do not generate small Office of Hazard Identification and of random sampling is to establish a parts may require more frequent testing Reduction, for Commission staff’s basis for inferring compliance about a than that required to assure that the rationale for selecting the 10,000 population of untested products from a paint used does not contain lead in number). The proposed rule would not set of tested products. If the products excess of the acceptable limits. The require periodic testing at every 10,000 selected for testing are not randomly appropriate periodic testing interval units manufactured; instead, once that selected, there is no statistical basis for may vary for a manufacturer depending threshold has been reached, the inferring the compliance of the untested

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products. Manufacturers may select the material change. Proposed should examine the product design for additional samples based on the § 1107.23(a) would state that, when a the children’s product as received by manufacturer’s knowledge of the material change is limited to a the consumer. For example, if a product and its production to provide component part of the finished children’s product has a component part greater assurance of compliance. For children’s product and does not affect that contains lead or has a sharp edge, example, if a manufacturer knows its the ability of the children’s product to but is inaccessible when the product is control over compliance degrades with meet other applicable children’s assembled, then the lead and sharp edge continuing production, the product safety rules, a manufacturer requirements would not be applicable to manufacturer may always test the last may issue a children’s product the finished product. Changes to a unit produced. Proposed § 1107.22 certificate based on the earlier third product’s design may result in a product would state that the production party certification tests and on test being subject to additional children’s population is the number of products results of the changed component part product safety rules. For example, if a manufactured or imported after the conducted by a third party conformity wooden button on a children’s product initial certification or last periodic assessment body. For example, if the is replaced with a plastic button, the testing of a children’s product. Proposed paint is changed on a children’s wooden button previously excluded § 1107.22 would allow a manufacturer product, issuance of a children’s from testing for lead content has been to use a procedure that randomly selects product certificate may be based on replaced with a component part that items from a list to determine which previous product testing and on tests of would be subject to testing for samples are the random samples for the new paint for compliance to lead, compliance with the lead content testing before production begins. For heavy metal, and phthalate requirements. example, if the planned production concentrations. Proposed § 1107.23(c) would state quantity in a period is 50,000, and 12 Proposed § 1107.23(a) also would that a material change in the random samples are to be selected for state that changes that cause a children’s manufacturing process is a change in periodic testing, before the products are product safety rule to no longer apply to how the children’s product is made that manufactured, a random process would a children’s product are not considered could affect the finished children’s have to identify which 12 of the 50,000 to be material changes. For example, product’s ability to comply with the will be selected for periodic testing. assume that a children’s product applicable children’s product safety Manufacturers that produce products consists of a cotton sweater with metal rules. For each change in the that continue to be distributed in buttons and that the children’s product manufacturing process, a manufacturer commerce as they are manufactured would be subject to the lead limits in should exercise due care to determine if may wish to test the random samples as section 101 of the CPSIA. If the compliance to an existing applicable they are selected to minimize the manufacturer decided to use wooden children’s product safety rule could be potential quantity of noncompliant buttons instead of metal buttons, the use affected or if the change results in a products if a test has failing test results. of wooden buttons would eliminate the newly-applicable children’s product Proposed § 1107.22 would allow need to test the product for lead, and the safety rule. The following are some manufacturers to select samples for change to wooden buttons, while examples of a material change to the testing as they are manufactured. arguably a change in the product’s manufacturing process of a children’s Proposed § 1107.22 would allow component parts, would not be a product: manufacturers who produce children’s ‘‘material change’’ under proposed • A new technique is used to fasten products that continue to be distributed § 1107.23(a) for the purposes of buttons to a doll’s dress which could in commerce as they are manufactured complying with the lead content limits. affect the children’s products ability to to test the samples as they become However, for other children’s product comply with the small parts rule; available instead of waiting until all the safety rules, such as small parts, the • New solvents are used to clean random samples have been selected change may be a material change. equipment employed in the before conducting testing. Proposed § 1107.23(a) also would manufacture of children’s products; the require a manufacturer to exercise due new solvents could affect the children’s d. Proposed § 1107.23—Material Change care to ensure that reliance on anything products ability to comply with the lead Proposed § 1107.23 would implement other than retesting of the finished content and phthalates requirements; the requirement in section 14(d)(2)(B)(i) product after a material change would and of the CPSA to test a children’s product not allow a noncompliant children’s • A new mold for an accessible metal when a material change has occurred. product to be distributed in commerce. component part of a children’s product Proposed § 1107.23(a) would state that if A manufacturer should resolve any is introduced into the assembly line a children’s product undergoes a doubts in favor of retesting the finished which could affect the children’s material change in product design or product for certification. Additionally, a products ability to comply with manufacturing process, including the manufacturer would be required to requirements for sharp edges. sourcing of component parts, that a exercise due care to ensure that any Proposed § 1107.23(d) would state manufacturer exercising due care knows component part undergoing component- that a material change in the sourcing of or should know that such material part-level testing is the same as the component parts results when the change could affect the product’s ability component part on the finished replacement of one component part of a to comply with the applicable children’s children’s product in all material children’s product with another product safety rules, the manufacturer respects. component part could affect compliance must submit a sufficient number of Proposed § 1107.23(b) would state with the applicable children’s product samples of the materially changed that, for purposes of proposed subpart safety rules. This would include, but is product for testing by a third party B, the term ‘‘product design’’ includes all not limited to, changes in component conformity assessment body. Such component parts, their composition, part composition, component part testing would be required before a and their interaction and functionality supplier, or the use of a different manufacturer could certify the when assembled. To determine which component part from the same supplier children’s product. The extent of such children’s product safety rules apply to who provided the initial component testing would depend on the nature of a children’s product, a manufacturer part.

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e. Proposed § 1107.24—Undue Influence redesign, changes in the manufacturing be maintained for 5 years. All records Proposed § 1107.24(a) would process, or changes in component part would be required to be available in the implement the requirement to safeguard sourcing. For existing production, English language. remedial action may include rework, against undue influence, pursuant to 4. Proposed Subpart D—Consumer repair, or scrap of the children’s section 14(d)(2)(B)(iv) of the CPSA, by Product Labeling Program requiring each manufacturer to establish product. If a remedial action results in procedures to safeguard against the a material change, the proposed rule a. Introduction exercise of undue influence by a would require a manufacturer to have a Proposed subpart D, consisting of one manufacturer on a third party third party conformity assessment body section, would implement the label conformity assessment body. retest the redesigned or remanufactured provision at section 14(d)(2)(A) of the Proposed § 1107.24(b)(1) would product before the manufacturer can CPSA. Section 14(d)(2)(A) of the CPSA require the procedures established certify the product. requires the Commission to initiate a under proposed § 1107.24(a) to include, g. Proposed § 1107.26—Recordkeeping program by which a manufacturer or at a minimum: Proposed § 1107.26(a) would require a private labeler may label a consumer • Safeguards to prevent attempts by children’s product manufacturer subject product as complying with the the manufacturer to exercise undue to an applicable children’s product certification requirements in section influence on a third party conformity safety rule to maintain the following 14(a) of the CPSA. assessment body, including a written records: b. Proposed § 1107.40 Labeling policy statement from company officials • Records of the children’s product Consumer Products To Indicate That the that the exercise of undue influence is certificate for each product. The Certification Requirements of Section 14 not acceptable, and directing that children’s product covered by the of the CPSA Have Been Met appropriate staff receive annual training certificate must be clearly identifiable Proposed § 1107.40(a) would allow on avoiding undue influence, and sign and distinguishable from other manufacturers and private labelers of a a statement attesting to participation in products; such training; • Records of each third party consumer product to indicate, by a • A requirement to notify the certification test. The manufacturer uniform label on or provided with the Commission immediately of any attempt must have separate certification tests product, that the product complies with by the manufacturer to hide or exert records for each manufacturing site; any consumer product safety rule under undue influence over test results; and • Records of the periodic test plan the CPSA, or with any similar rule, ban, • A requirement to inform employees and periodic test results for a children’s standard or regulation under any other that allegations of undue influence may product; act enforced by the CPSC. be reported confidentially to the • Records of descriptions of all Proposed § 1107.40(b) would require Commission and to describe the manner material changes in product design, the label to be printed in bold typeface, in which such a report can be made. manufacturing process, and sourcing of using an Arial font of not less than 12 points, be visible and legible, and state f. Proposed § 1107.25—Remedial Action component parts, and the certification tests run and the test values; ‘‘Meets CPSC Safety Requirements’’. Proposed § 1107.25(a) would require • Records of the undue influence The Commission considered whether each manufacturer of a children’s procedures, including training materials a shorter label statement would product to have a remedial action plan and training records of all employees adequately convey the intended that contains procedures the trained on these procedures; and message and concluded that it would manufacturer must follow to investigate • Records of all remedial actions not. Acronyms such as ‘‘CPSIA’’ or and address failing test results. A taken following a failing test result, ‘‘CPSA’’ were considered. However, the manufacturer would be required to take including the rule that was tested, the Commission concluded that the remedial action after any failing test specific remedial action taken, the date meaning of the acronym might not be result to ensure, with a high degree of the action was taken, the person who known to a sufficient number of people. assurance, that the children’s products authorized the action, any test failure Further, even those persons who might manufactured after the remedial action which necessitated the action, and the know what the acronyms stood for has been taken comply with all results from certification tests showing would not necessarily know why it was applicable children’s product safety compliance after the remedial action marked on the label or product. The rules. was taken. acronym ‘‘CPSC’’ might be more widely Proposed § 1107.25(b) would not Proposed § 1107.26(b) would require a recognized, but viewers still may not permit a manufacturer to certify a manufacturer to maintain the records know why it is present. Further, the product if any certification test by a specified in subpart C at the location Commission does not want the presence third party conformity assessment body within the United States specified in 16 of a ‘‘CPSC’’ marking on a label, package, results in a failure, until the CFR 1110.11(d) or, if the records are not or product to give the impression that manufacturer has taken remedial action maintained at the custodian’s address, the CPSC has tested, approved, or and the product manufactured after the at a location within the United States endorsed the product. remedial action passes certification specified by the custodian. The The Commission also considered the testing. manufacturer would be required to statement ‘‘Meets CPSC Requirements,’’ Proposed § 1107.25(c) would require a make these records available, either in but this statement did not seem very manufacturer whose children’s product hard copy or electronically, for informative for persons who did not has received a failing test result to take inspection by the CPSC upon request. recognize the term ‘‘CPSC.’’ Inserting the remedial action to ensure, with a high Proposed § 1107.26(c) would require a word ‘‘safety’’ to form the statement degree of assurance, that the children’s manufacturer to maintain records ‘‘Meets CPSC Safety Requirements’’ product complies with all applicable (except for test records) for as long as would convey the message that the children’s product safety rules. The the product is in production or product met some safety requirements, proposal would state that remedial imported by the manufacturer plus 5 even to those persons who are not action can include, but is not limited to, years. Test records would be required to familiar with CPSC. Giving the full

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name of the CPSC would make the 2. Objectives and Legal Basis for product safety rule as a secondary or statement too long to be practical in Proposed Rule tertiary activity might not have been some cases, and the length could The Commission is proposing this counted. There is no separate NAICS discourage viewers from reading the rule to implement sections 14(a) and category for importers. Firms that message. Therefore, the proposal would 14(d)(2)(A) and (B) of the CPSA, as import product might be classified as have the statement say ‘‘Meets CPSC amended by the CPSIA. The objective of manufacturers, wholesalers, or retailers. Safety Requirements’’ to indicate that the rule is to reduce the risk of injury a. Manufacturers the product has been certified by the from consumer products, especially manufacturer or private labeler as from products intended for children According to the criteria established complying with all applicable safety aged 12 years and younger. The rule by the Small Business Administration requirements enforced by CPSC. will accomplish this objective by (SBA), manufacturers are generally considered to be small entities if they Proposed § 1107.40(c) would allow a requiring that manufacturers of have fewer than 500 employees. Table 2 consumer product to bear the label if the nonchildren’s products that are subject shows the number of manufacturers that manufacturer or private labeler has to consumer product safety rules are classified by the NAICS categories certified, pursuant to section 14 of the develop and maintain a reasonable that cover most children’s and general CPSA, that the consumer product testing program that provides a high degree of assurance that their products use products that are subject to a complies with all applicable consumer consumer product safety rule. Although product safety rules under the CPSA conform to all the applicable safety standards. For children’s products, an there are more than 36,000 and with all rules, bans, standards, or manufacturers that would be considered regulations applicable to the product additional layer of protection is provided by requiring that certain small in these categories, not all of these under any other act enforced by the firms are engaged in manufacturing Consumer Product Safety Commission. testing be performed by a third party conformity assessment body. The children’s products or general use Proposed § 1107.40(d) would allow a proposed testing programs should allow products that are subject to a consumer manufacturer or private labeler to use manufacturers to discover noncompliant product safety rule. It would be another label on the consumer product products and take the necessary expected that most of the firms engaged as long as such label does not alter or corrective actions to keep noncompliant in Doll, Toy, and Game manufacturing mislead consumers as to the meaning of products from entering commerce or to produce some products that are the label described in proposed remove them expeditiously if they have intended for children age 12 and § 1107.40(b). A manufacturer or private been introduced into commerce. younger. On the other hand, All Other labeler would not be allowed to imply Miscellaneous Chemical Product and that the CPSC has tested, approved, or 3. Number of Small Firms Impacted Preparation Manufacturing includes endorsed the product. The number of firms that could be some products such as matchbooks and impacted was estimated by reviewing fireworks, subject to consumer product D. Regulatory Flexibility Act every category in the North American safety rules but also includes products, 1. Introduction Industrial Classification System such as distilled water and hydraulic (NAICS) and selecting those firms that fluids, that are not subject to consumer The Commission has examined the manufacture or sell any consumer product safety rules. All Other impact of the proposed rule under the product that could be covered by a Miscellaneous Electrical Equipment and Regulatory Flexibility Act (5 U.S.C. 601 consumer product safety rule. These Component Manufacturing includes through 612). The Regulatory Flexibility firms include any establishment that consumer products such as garage door Act requires agencies to analyze could manufacture or sell a openers as well as non consumer regulatory options that would minimize nonchildren’s product or children’s products such as particle accelerators. any significant impact of a rule on small products. Firms are classified by an The Surgical Appliance and Supplies entities. The Commission has conducted NAICS code that describes their primary Manufacturing category includes an initial regulatory flexibility analysis activity. Therefore, firms that might bicycle helmets, but most of the other of the proposed rule regarding the manufacture or import consumer products in this category are not under potential impact on small entities. products covered by a consumer CPSC jurisdiction.

TABLE 2—MANUFACTURERS

NAICS code Description Small firms Total firms

31411 ...... Carpet and Rug Mills ...... 261 284 31519 ...... Other Apparel Knitting Mills (Outerwear, Underwear, and Sleepwear) ...... 235 246 3152 ...... Cut and Sew Apparel Manufacturing ...... 9,313 9,388 3159 ...... Apparel Accessories and Other Apparel Manufacturing ...... 907 920 316211 ...... Rubber and Plastic Footwear Manufacturing ...... 52 56 316212 ...... House Slipper Manufacturing ...... 2 2 316219 ...... Other Footwear Manufacturing ...... 68 69 321911 ...... Wood Window and Door Manufacturing ...... 1,241 1,297 32551 ...... Paint and Coating Manufacturing ...... 1,042 1,093 325998 ...... All Other Misc. Chemical Product and Preparation Manufacturing ...... 957 1,045 326191 ...... Plastics Plumbing Fixture Manufacturing ...... 465 488 326299 ...... All Other Rubber Product Manufacturing ...... 633 681 332321 ...... Metal Window and Door Manufacturing ...... 1,071 1,138 332998 ...... Enameled Iron and Metal Sanitary Ware Manufacturing ...... 60 72 333112 ...... Lawn and Garden Tractor and Home Lawn and Garden Equip. Mfg...... 117 134 33422 ...... Radio, Television Broadcasting and Wireless Comm. Equip. Mfg...... 811 894 335222 ...... Household Refrigerator and Home Freezer Manufacturing ...... 12 18

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TABLE 2—MANUFACTURERS—Continued

NAICS code Description Small firms Total firms

335999 ...... All Other Misc. Electrical Equipment and Component Mfg...... 737 791 336991 ...... Motorcycle, Bicycle, and Parts Manufacturing ...... 456 466 33712 ...... Household and Institutional Furniture Manufacturing ...... 6,052 6,179 33791 ...... Mattress Manufacturing ...... 448 462 339113 ...... Surgical Appliance and Supplies Manufacturing ...... 1,601 1,691 33991 ...... Jewelry and Silverware Manufacturing ...... 2,737 2,752 33992 ...... Sporting and Athletic Goods Manufacturing ...... 1,886 1,930 33993 ...... Doll, Toy and Game Manufacturing ...... 763 776 339999 ...... All Other Miscellaneous Manufacturing ...... 4,440 4,499

Total Manufacturers ...... 36,367 37,371 Source: U.S. Census Bureau, 2006 County Business Patterns.

b. Wholesalers 3 shows the number of wholesalers by are subject to a consumer product safety NAICS code that would cover most rule. A significant proportion of the Wholesalers would be impacted by children’s products and general use firms classified as Toy and Hobby the proposed rule if they import any products that are subject to a consumer Goods and Supplies Merchant children’s products or general use product safety rule. According to the Wholesalers probably import at least products that are subject to a consumer SBA criteria, wholesalers are generally some children’s products. However, the product safety rule. Wholesalers that considered to be small entities if they only firms classified as Motor Vehicle obtain their products strictly from have fewer than 100 employees. and Motor Vehicle Parts and Suppliers domestic manufacturers or from other Although there are more than 77,000 would be those that import all terrain wholesalers would not be impacted by wholesalers that would be considered vehicles or other off-road vehicles, the proposed rule since the small in these categories, not all of these especially those intended for children manufacturer would be responsible for firms are engaged in importing age 12 years and younger. testing and certifying the product. Table children’s or general use products that

TABLE 3—WHOLESALERS

NAICS Code Description Small firms Total firms

4231 ...... Motor Vehicle and Motor Vehicle Parts and Suppliers ...... 16,947 17,858 4232 ...... Furniture and Home Furnishing Merchant Wholesalers ...... 10,534 10,981 42362 ...... Electrical and Electronic Appliance, Television, and Radio Set Merchant Wholesalers ...... 2,147 2,269 42391 ...... Sporting and Recreational Goods and Supplies Merchant Wholesalers ...... 4,397 4,552 42392 ...... Toy and Hobby Goods and Supplies Merchant Wholesalers ...... 2,170 2,248 42394 ...... Jewelry, Watch, Precious Stone, and Precious Metal Merchant Wholesalers ...... 7,735 7,815 42399 ...... Other Miscellaneous Durable Goods Merchant Wholesalers ...... 10,146 10,367 42432 ...... Men’s and Boy’s Clothing and Furnishings Merchant Wholesalers ...... 3,235 3,393 42433 ...... Women’s, Children’s, and Infant’s Clothing, and Accessories Merchant Wholesalers ...... 5,965 6,186 42434 ...... Footwear Merchant Wholesalers ...... 1,434 1,493 42499 ...... Other Miscellaneous Nondurable Goods Merchant Wholesalers ...... 12,497 12,753

Total ...... 77,207 79,915 Source: U.S. Census Bureau, 2006 County Business Patterns.

c. Retailers bodies. The number of such retailers is million ($25 million in the case of not known. Table 4 shows the number general merchandise stores). Although Retailers that obtain all of their of retailers by NAICS code that would there are more than 125,000 that would products from domestic manufacturers cover most children’s products. be considered to be small businesses in or wholesalers will not be directly According to the SBA criteria, retailers these categories, it is not known how impacted by the proposed rule, since are generally considered to be small many of these firms are engaged in the direct impact of the proposed rule entities if their annual sales are less importing or manufacturing children’s would be experienced by the than $7 million ($27 million in the case or general use products that are subject manufacturer. However, there are some of general merchandise stores). Because to a consumer product safety rule. Many retailers that manufacture or directly of the way in which the data were of these firms probably obtain all of import some products and, therefore, reported, Table 4 shows the total their products from domestic would be responsible for ensuring that number of firms in each of the wholesalers or manufacturers and these products are subjected to testing categories that operated all year and the would not be directly impacted by the by third party conformity assessment number with sales of less than $5 rule.

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TABLE 4—RETAILERS

NAICS Code Description Small firms Total firms

441221 ...... Motorcycle, ATV, and Personal Watercraft Dealers ...... 3,969 4,001 4421 ...... Furniture Stores ...... 16,282 17,542 44813 ...... Children’s and Infant’s Clothing Stores ...... 2,146 2,200 44814 ...... Family Clothing Stores ...... 5,998 6,240 4482103 ...... Children’s & juveniles’ shoe stores ...... 300 305 4483 ...... Jewelry, luggage, & leather goods stores ...... 16,341 16,778 45111 ...... Sporting goods stores ...... 14,451 14,831 45112 ...... Hobby, toy, & game stores ...... 4,832 4,903 452 ...... General Merchandise Stores ...... 7,387 7,494 45322 ...... Gift, Novelty, and Souvenir Store ...... 21,412 21,637 453998 ...... All Other Misc. Store Retailers (except Tobacco Stores) ...... 11,934 12,228 4542 ...... Vending machine operators ...... 4,081 4,278 45439 ...... Other direct selling establishments ...... 15,938 16,431

Total ...... 125,071 128,868 Source: U.S. Census Bureau, 2002 Economic Census, Release date 11/25/2005.

4. The Potential Effects of the Proposed program for production testing. b. Third Party Testing of Children’s Rule Statistical skills or statistical Products consultants may be required to a. Reasonable Testing Program The proposed rule would establish determine the frequency, sample size, requirements for the continued testing The proposed rule would require any and collection method for production of children’s products by third party manufacturer of a nonchildren’s product testing. For some production tests, conformity assessment bodies for to establish a reasonable testing program professionals such as engineers or certification, periodically, and when for the product unless they test every chemists might be required, depending there has been a material change in the product. Most manufacturers probably upon the consumer product safety rules products design or manufacturing have some quality control programs in applicable to the product. In some cases, process, including the sourcing of place that are intended to demonstrate the production tests could be carried out component parts. that the products as manufactured meet by the firm’s production workers or Manufacturers will have to develop the manufacturer’s specifications, technicians, perhaps working under the and maintain records that demonstrate including their specifications for supervision of an engineer, chemist, or compliance with the third party testing complying with any safety regulations. similar professional. When the requirements. The Commission In some cases, these programs would manufacturer does not have the internal welcomes comment on these meet the requirements of the reasonable capability to perform some of the requirements, including comments on testing program as described in the required production testing, the testing the possible burden that these proposed rule. Other manufacturers may may need to be performed by a third recordkeeping requirements might have to modify their current programs to party testing assessment body. impose. ensure that they meet the requirements The cost to firms of complying with It is expected that the cost of the third of the proposed rule. For example, some this provision of the proposed rule party testing requirements could have a manufacturers might have to modify would depend upon the extent of the significant impact on a substantial their programs to ensure that the testing changes that firms will have to make to number of small entities. The cost of program adequately covers all consumer their existing testing programs. For third party testing is influenced by product safety rules that are applicable firms that already have testing programs many factors, including the amount and to their products. Some manufacturers that would meet the requirements of the skill of the labor required to conduct the might have to increase their testing proposed rule, there could be no tests, the cost of the equipment frequency. Some manufacturers might additional costs. For other firms, the involved, the cost of transporting the have some informal testing programs cost of complying with the requirements product samples to the test facility, and that would have to be formalized and of the proposed rule will depend upon the geographic area where the tests are better documented. There may also be several factors, including the conducted. Some tests require a some manufacturers that do not have a characteristics of their products and the substantial amount of time to conduct program in place. These firms will have steps that the firm will have to take to including the preparation of the sample. to develop reasonable testing programs. comply with the requirements. Because It might take a couple of days, for Compliance with the proposed rule of the wide variety of products and example, to test a bicycle for would require a variety of professional manufacturers that would be covered by compliance with the bicycle standard skills on the part of manufacturers. the proposed rule and because the (16 CFR part 1512). Similarly, a chemist Lawyers may be required to review characteristics of each product and the testing the lead content of a product CPSC regulations in order to determine circumstances of each firm are different, might be able to test only a few which regulations are applicable to a the Commission cannot reliably component parts a day due to the product. Depending upon the specific estimate the cost to manufacturers of the amount of time required to prepare the product and the safety rules that are reasonable testing program requirement samples and to clean and calibrate the applicable to it, people with knowledge of the proposed rule. The Commission equipment between tests. of subjects such as engineering and invites comments that provide more It should be noted that the price that chemistry may be required to develop information on the cost and other a given manufacturer pays for testing is the product specifications, conduct the impacts of this requirement on often the result of negotiations between certification tests, and to design a manufacturers. the testing laboratory and the

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manufacturer. Manufacturers that do a testing one bicycle may range from ii. Cost of Third Party Testing by large volume of business with a testing around $700, if the testing is performed Product laboratory can frequently obtain in China, to around $1,100 if the testing The cost to obtain the required third substantial discounts on the laboratory’s is performed in the United States. A normal charges, whereas manufacturers party testing for a product depends on manufacturer that needs several models the types and number of tests that must that do only a small volume of business of bicycle tested at the same time might may not. be performed on each product, the size be able to obtain discounts from these of the sample that is required to provide Some information on the cost of third prices. However, this does not include party testing for some of the applicable a high degree of assurance that the the testing of component parts for lead tests is provided below. The information products comply with the applicable and phthalates, which would add to the was collected from a number of sources, safety rules, and the extent to which including published price lists from costs of bicycle testing. component part testing can be used. some testing laboratories, conversations Bicycle Helmets: One laboratory Because of the wide variety of with representatives of testing quoted a price of $600 for testing one manufacturers, and importers, and laboratories, and actual invoices model of a bicycle helmet to the CPSC products that would be affected by the provided by consumer product bicycle helmet standard. A price list proposed rule, we cannot provide manufacturers. The data are not based from another laboratory stated that comprehensive estimates of the impact upon a statistically valid survey of conducting the certification testing to of the proposed rule on all products or testing laboratories. Additionally, the the Snell Foundation’s bicycle helmet firms. The discussion immediately costs are only the costs that would be standard (which is similar to the CPSC below is intended to provide some charged by the testing laboratory and do standard, but considered by some to be perspective on the potential impact. The not include the costs of the products more stringent) was $830. Commission invites additional public consumed in destructive tests or the comments on the discussion and more cost of shipping the samples to the Full-Size Cribs: As with bicycles, specific information on the impact and laboratories. testing cribs requires a substantial cost of the third party testing amount of labor time to assemble the requirements of the proposed rule. i. Costs Associated With Various Third crib, take the appropriate measurements Party Tests The third party testing costs discussed and perform the required tests. The cost in this section apply to the costs Lead Content and Lead-in-Paint: The of testing a full-size crib will be around associated with either the periodic cost per component part for testing for $1,200 in the United States. The cost testing requirement or the requirement lead content and lead-in-paint using can vary depending on the features of that additional third party testing be inductively coupled plasma (ICP) the individual cribs that require testing conducted if there is a material change analysis will range from a low of about and between laboratories. Some in the product’s design or $20 per test to more than $100 per test. manufacturers might receive discounted manufacturing process. However, in the The lowest per unit cost represents a prices. This does not include testing the latter case, the testing might be limited substantially discounted price charged crib for lead and phthalates, which, to to those rules where compliance might to a particular customer by a laboratory the extent necessary, would add to the have been impacted by the change. in China and might not be typical. cost of testing a crib to all applicable Number of units for testing: The Within the United States, typical prices safety rules. range from around $50 to more than proposed rule would require the $100 per test. Toys: The ASTM F963 toy standard manufacturer to submit enough units to The cost of testing for lead content was made a mandatory standard by the the conformity assessment body to using XRF technology is significantly CPSIA. The standard includes a wide provide a high degree of assurance that less expensive. Some firms have offered variety of tests, including tests for the products comply with the applicable to screen products for lead content for soluble heavy metals in surface coatings consumer product safety rules. The as little as $2 per test. These offers were and for various physical and mechanical exact number will depend upon the generally directed to stores or criteria. Based on the itemized prices on characteristics of the product, the lot businesses that wanted to check their several invoices from testing size, whether the tests produce inventory for conformity with the laboratories that have been provided to quantitative or qualitative data, whether retroactive lead content requirements CPSC staff or otherwise made public, the product has an established that were contained in the CPSIA. Some the cost of the physical and mechanical reasonable testing program, and the testing laboratories will charge for XRF tests range from about $50 to $245. The interpretation of a high degree of assurance. A discussion of the statistical testing at an hourly rate, which can be cost of the chemical test for the presence aspects of designing a sampling plan around $100. Ten to 30 components of heavy metals ranges from about $60 was presented by Dr. Michael Greene of parts can be tested in an hour. However, to $190 per surface coating. Again, these with the exception of some plastics, the CPSC staff at the Product Testing costs do not include testing for lead and Workshop on December 10, 2009. XRF is not acceptable for all phthalates, which add to the total cost. certification purposes. Quantitative testing data is data where Phthalates: The cost of testing for The flammability requirements of the relevant variable can be measured phthalate content will range from ASTM F963 were not made mandatory with some degree of precision. For around $100 (a discounted price by a by the CPSIA, but the Commission was example, the lead content of a substance laboratory in China) to about $350. directed to examine the flammability can be measured in terms of parts per These are the costs per component part requirements and consider million (ppm). Qualitative data is where and include testing for all six of the promulgating rules addressing the issue. the outcome of a test is simply a ‘‘pass’’ prohibited phthalates specified in the If some flammability tests are eventually or ‘‘fail.’’ For example, in a drop test the CPSIA. required, the cost per test could be in result might simply be whether a sharp Bicycle Standard: According to one the range of $20 to $50 based on some edge was exposed (a ‘‘fail’’) or a sharp testing laboratory, it takes 1 to 2 days to observed costs for the ASTM F963 edge was not exposed (a ‘‘pass’’). When test a bicycle. The estimated price for flammability tests. the data is qualitative, the sample size

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will usually have to be larger than when products are in compliance and a lot sizes by mean and standard the data is quantitative. manufacturer is testing a component deviation (assuming a normal For example, as of August 14, 2011 part for lead content, then the distribution). Larger sample sizes would the lead content of children’s products manufacturer could determine the be required for products with higher must be no greater than 100 ppm unless appropriate sample size if it knew the means, larger standard deviations, and the Commission determines that a limit mean lead content of the component larger lot sizes. Smaller sample sizes of 100 ppm is not technologically part, the standard deviation about the would be required for products with feasible for a product or product mean, and the size of the lot that was lower means, standard deviations and category. If, for illustrative purposes, a to be tested. Table 5 shows the sample lot sizes. high degree of assurance means at least sizes that would be required to provide a 95 percent probability that all a high degree of assurance for different

TABLE 5—SAMPLE SIZES REQUIRED TO PROVIDE AT LEAST 95 PERCENT PROBABILITY THAT THE LOT IS COMPLIANT (GIVEN THE AVAILABILITY OF QUANTITATIVE TEST DATA)

Standard deviation Sample size Probability that the Mean (ppm) (ppm) Lot size (units) (units) lot is compliant

10 ...... 1 1,000 4 .998 10 ...... 1 2,500 4 .995 10 ...... 1 10,000 4 .992 10 ...... 1 25,000 5 .978 10 ...... 1 50,000 5 .957 15 ...... 3 1,000 5 .993 15 ...... 3 2,500 5 .983 15 ...... 3 10,000 6 .992 15 ...... 3 25,000 6 .981 15 ...... 3 50,000 6 .962 35 ...... 5 1,000 6 .965 35 ...... 5 2,500 7 .976 35 ...... 5 10,000 8 .972 35 ...... 5 25,000 9 .978 35 ...... 5 50,000 9 .957

Where only qualitative (e.g., pass/fail) 10,000 units, there would be a 95 finished product. If, following the testing data is available, the sample percent probability that no more than sample sizes in Table 5, the mean of the sizes needed to provide a high degree of 600 of the products would be component was 10 and the standard assurance will be higher than those in noncompliant. If a higher level of deviation was 1, this would reduce the Table 5. Such tests include some of the assurance were required, the sample cost of testing that component part by a use and abuse tests for testing children’s size would have to be larger. If a lower factor of four over the cost that would products (e.g., the drop test). As level of assurance were acceptable the apply if only tests on the finished discussed by Dr. Michael Greene at the sample size could be smaller. product were acceptable. This is CPSIA Product Testing Workshop, more The examples in Table 5 illustrate the because without component part testing, samples may be necessary because there disproportionate impact that the the manufacturer would have to is more uncertainty in the test data. In proposed rule could have on small conduct tests on the component part as other words, with only pass/fail data, it businesses or businesses with low- it was used in each of the five products. is not known if the result was close to volume products. In the first example in If each product were produced in lots of the threshold or far from the threshold. Table 5, the same number of units 10,000 units, this would amount to four In these cases, it might be necessary to would have to be submitted to a third tests on the component for each product define a high degree of assurance as a party testing conformity assessment or 20 total tests on the same component probability that no more than a given body whether 1,000 units or 10,000 part. With component part testing, the proportion of noncompliant products. units were in the lot. In other words, the manufacturer could simply conduct the For example, as discussed by Dr. Greene total third party testing costs would be tests on the component part, which was at the Product Testing Workshop, a 95 the same, but the cost per unit for a assumed to be purchased in a lot of percent probability that no more than a manufacturer producing only 1,000 50,000 units, which would only require certain proportion ‘‘p’’ of the units in a units would be 10 times the cost per five tests of the component to provide lot do not comply is approximately unit for a manufacturer producing a 95 percent probability that all of the given by the formula p ≈ 3/k, where ‘‘k’’ 10,000 units. units in the lot were in compliance. is the sample size. Thus, if 50 items The examples in table 5 also illustrate Random Samples: The proposed rule were tested and no noncompliant items the potential that component part would require that samples for periodic were found, there is a 95 percent testing could offer for reducing the cost testing for children’s products be probability that no more than 6 percent of testing. For example, assume a selected randomly. A random sample is of the items in the lot do not comply. manufacturer produces five products in one in which each unit has an equal In other words, if the lot size were 1,000 lots of 10,000 units, but uses a common chance of being included in the sample. and 50 units were tested and no component part on each of the products The proposed rule would specify that noncompliant product were found, that it purchases in lots of 50,000. The each unit produced or imported by the there is a 95 percent probability that no manufacturer could conduct the firm since the last random sample was more than 60 units in the entire lot are applicable chemical tests on the drawn must have an equal chance of not in compliance. If the lot size were component part rather than on the being selected. There will be some

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additional cost associated with selecting provide the required high degree of that testing four units could statistically a random sample rather than a assurance, then the cost of the third provide the required high degree of convenience sample. The Commission party testing to the manufacturer would assurance, then the cost the chemical invites comments on this proposed be $18,600. testing for this toy would be $4,848 provision and is especially interested in The manufacturer in this example ($1,212 × 4). If the means or standard comments describing the cost or other might be able to reduce the testing costs deviations of the lead, heavy metal, or burdens that this proposed provision with component part testing if some of phthalate content were higher, which is would impose. the components parts were used on likely the case for some materials, more more than one model. If component part units might have to be tested to provide iii. Hypothetical Product Testing testing reduced the cost of the lead the required high degree of assurance Examples content testing by this manufacturer by and the resulting cost would also be To provide some information on what a factor of four, then the cost of testing higher. the magnitude of the third party testing to the bicycle standard itself would still Because the testing data for costs may be for some manufacturers of be $900, but the average cost of testing mechanical requirements are qualitative children’s products, this section the lead content of the component parts in nature, the number of units that discusses the potential cost of would be reduced to $12.50 per might have to be tested to provide the conducting third party testing for two component part. Therefore the cost of required high degree of assurance would product categories: Bicycles and toys. testing the bicycle once would be be more than required for the chemical These examples are hypothetical and $1,837.50. The cost to test four units to tests. If a high degree of assurance were are intended to illustrate some potential provide the required high degree of considered to be a 95 percent cost implications of the proposed rule assurance would be $7,350. probability that no more than 6 percent but might not be representative of every The total cost of the third party testing of the units in the lot did not comply, manufacturer in each category. The to the manufacturer would depend upon then 50 units would have to be tested. costs per test that are assumed in the the number of youth model bicycles that In this case, the cost of mechanical examples can vary significantly. The the manufacturer offered. If the testing would be $2,500 ($50 × 50). Commission invites any comments that manufacturer had five different models, Combining the cost of the chemical provide better information on the and if component part testing could tests and the cost of the tests for potential impacts on individual reduce the costs of the lead-content mechanical or physical requirements, manufacturers. testing by a factor of four, the total cost the total cost to this hypothetical Bicycles: Children’s bicycles must be of the third party testing to the firm manufacturer to obtain the required tested for compliance with the CPSC would be about $36,750. high degree of assurance that the bicycle standard, which was estimated Toys: Toys are subject to the products complied with all applicable above to cost between $700 and $1,100. requirements for lead and phthalate safety rules would be $7,348. If, as in Additionally, the paint used on the content, and to several physical and the bicycle example, component part bicycle must be tested for compliance mechanical requirements, including the testing could be used to reduce the cost with the lead-in-paint standard and the requirements of ASTM F963, which was of the chemical testing by a factor of accessible component parts on the made a mandatory standard by the four, then the total cost of testing the toy bicycle must be tested for lead content. CPSIA. In this example, it is assumed could be reduced to $3,712 ($4,848/4 + The number of paints and component that the testing costs are at the low to $2,500). parts that require testing can vary middle part of the ranges and that the Again, the total cost to the among different models, but information hypothesized toy contains one metal manufacturer would depend upon provided by CPSC Compliance staff component part that must be tested for factors such as the complexity of the suggests that 75 components parts might lead content using ICP analysis (at $50) products, the variation in the materials be a reasonable estimate for the average. and two plastic component parts for used, the opportunities to use This example will use estimates in the which XRF analysis can be used for component part testing, and the number middle of these ranges for the testing determining the lead content (two tests of different toys that were offered. For costs discussed above and assume that at $6 each). The plastic component parts example, if the manufacturer offered the cost of testing to the bicycle also must be tested for phthalate content five similar toys and the third party standard is $900 and the cost for testing (two tests at $225 each). Additionally, it testing costs were similar for each toy a component part for lead content is is assumed that the toy contains four and component part testing allowed the $50. It is further assumed that different paints that must be tested for manufacturer to reduce the costs of quantitative data is available for all both lead content ($50/test) and soluble chemical testing by a factor of four, the applicable tests and that the variation is heavy metals ($125/test). Finally, it is total cost to the manufacturer for testing low enough that testing four units will assumed that the toy is subject to some the toys would be $18,560. The annual provide the high degree of assurance mechanical requirements that include cost would be higher if the testing had desired that products comply with the use and abuse testing for which only to be repeated more than once annually applicable safety rules. To the extent qualitative data is available at $50 per or there were material changes in the that some of the tests in the bicycle test. Thus, the cost of testing this toy for design of the products or production standard might be qualitative in nature, compliance to each applicable rule one processes during the year. the sample size for testing would need time would be $1,262: $1,212 is to be larger. associated with the chemical (lead, iv. Impact of Third Party Testing on If component part testing is not heavy metal, and phthalate) testing and Firms available to this manufacturer, the cost $50 is associated with the mechanical Whether such costs would have a of testing the bicycle to each applicable testing (including use and abuse substantial adverse impact on a firm safety rule one time would be about testing). depends upon the individual $4,650 (testing to the bicycle standard If the means and standard deviations circumstances of the firm. One factor itself at $900 and testing 75 components of the lead, heavy metal, and phthalate that can give an indication of whether parts for lead content). If a sample of contents of all of the product something will have a significant impact four units were required to be tested to components parts are sufficiently low is the magnitude of the impact in

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relation to the revenue of the firm. A another test. For some chemical tests, it This could be especially important for typical profit rate is about 5 percent of may be necessary to use more than one firms that expected to serve a niche revenue. In other words, for every $1 of sample of the product to obtain enough market, including products intended for revenue, only 5 cents might remain after of a component to test.) If the children with special needs. The paying all expenses. Therefore, a new manufacturer received $4 for each unit, requirement for third party testing when cost that amounted to 1 percent of then the periodic third party testing there is a material change in a product’s revenue could, all other things equal, costs would amount to about 1.5 percent design or manufacturing process could reduce the profit by 20 percent and of revenue ($0.06/$4), which still could cause some small or low-volume might be considered to be a significant be considered to be a significant impact. manufacturers to forgo or delay impact by some firms. This would be If component part testing reduced the implementing some improvements to a consistent with what some other cost of the chemical tests by a factor of product’s design or manufacturing agencies consider to be significant. four, then the cost of the periodic third process in order to avoid the cost of the OSHA, for example, considers an party testing could be reduced to $353 third party testing. impact to be significant if the costs ($50 + $1,212/4) or about $0.02 per unit, exceed 1 percent of revenue or 5 percent if 10,000 units were produced annually The cost of testing some toys and of profit. and third party testing were conducted other children’s products could be Using the toy example above, with only once every two years. This would higher than those in the above component part testing, if the third be about 0.5 percent of revenue if the examples. The cost would be higher, for party testing costs were spread over manufacturer received $4 for each unit, example, for products that had more 10,000 units, the cost of the testing which might not be considered components parts or where the would be about $0.37 per unit ($3,712/ significant. If the production volume variability in the test results was greater, 10,000). According to a toy industry were lower or the revenue per unit which would require more samples to representative, the average retail price of received by the manufacturer were be tested. The cost of testing would also a toy is about $8. However, depending lower, the impact would be greater. If be higher if there was less opportunity upon the channels of distribution and the production volume were higher or for component part testing. The cost of the practices in the particular market or the revenue per unit received by the testing could be lower for products that industry, the price that a manufacturer manufacturer were higher, then the were subject to fewer safety rules or that receives for a product can be less than impact of the third party testing contained fewer component parts. For half of what the product eventually sells requirement would be lower. some apparel articles, for example, the for at retail. Therefore, if the It should be noted that the only cost only tests required might be for lead manufacturer received $4 for the toy considered in this hypothetical example content on some components parts for that cost $0.37 per unit to test, the third is the cost of the third party testing. Any which component part testing might be party testing costs would be 9.2 percent additional costs associated with in- permissible. of revenue ($0.37/$4) and could exceed house periodic testing or a reasonable the expected profit. Even if the testing program would be in addition to Although the above examples manufacturer received $30 per unit for these costs and increase the impact, as illustrate the potential for component the toy (which might indicate a retail would any additional third party testing part testing to reduce the costs of price of around $60 or more), the third costs associated with material changes testing, it might not be an option for all party testing cost would still exceed 1 in the product’s design, the products or manufacturers. Component percent of the revenue per unit and manufacturing processes, or the part testing is most likely to be an might be considered to be a significant sourcing of component parts. Other option for component parts that are impact. costs that were not considered were the common to multiple products (e.g., It is possible that the impact could be cost of the samples consumed in the paints, bolts of a standard size). The reduced if the manufacturer had an testing and the cost of shipping the potential for component part testing to established reasonable testing program samples to the third party conformity reduce the cost of testing would be less that met the requirements of the assessment body. for products that have component parts proposed rule. In such cases, that are unique to that product. manufacturers would be required to v. Caveats and Possible Market conduct periodic third party tests per Reactions to Third Party Testing 5. Protection Against Undue Influence rule at least once every two years rather Requirements The proposed rule would require all than at least once a year. For example, Manufacturers can be expected to manufacturers of children’s products to if the hypothetical manufacturer of the react to a significant increase in their establish procedures to prevent attempts toy used in the above example had a costs due to testing requirements in reasonable testing program and several ways. Some manufacturers to exercise undue influence on a third determined that obtaining one periodic might attempt to redesign their products party conformity assessment body and third party test per applicable rule were to reduce the number of tests required, to report to the Commission sufficient, and the annual production by reducing the features or the number immediately of any attempt by any volume were 10,000 units, then the per of components parts used in their interested party to exert undue unit testing cost (without any products. Manufacturers could also be influence over test results, and that component testing) would be about expected to reduce the number of employees are aware that they may $0.06 ($1,262/20,000). (However, it children’s products that they offer or, in report any allegations of undue should be noted that testing a product some cases, exit the market for influence to the Commission for compliance with each applicable children’s products entirely. Some may confidentially. There would be some rule one time is likely to require that the go out of business altogether. cost to firms to develop the materials or manufacturer submit more than one The requirement for third party training programs to comply with these sample of the product to the testing certification testing could be a barrier to requirements. The Commission invites laboratory. This is because some new firms entering the children’s comments from the public providing required tests cannot be performed on product market, unless they expect to information on the cost and other the same sample that has been used for have relatively high volume products. impacts of this provision.

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6. Consumer Product Labeling Program and certification of consumer products. a. Partial Exemption From Periodic The consumer product labeling Some individual consumer product Testing program that would be established by safety rules contain specific testing The proposed rule would require that the proposed rule would allow firms to requirements. Manufacturers would be all children’s products be tested label any product that complies with the expected to meet the more stringent periodically by a third party conformity certification requirements for the requirements whether they are the assessment body and establishes one provisions of this proposed rule or the product with a label that states that the year as the maximum interval between requirements in the specific safety rule. product ‘‘Meets CPSC Safety third party periodic tests if the However, the rules would not require Requirements.’’ This provision is not manufacturer does not have a manufacturers to duplicate their efforts expected to have a significant impact on reasonable testing program and two to comply with both sets of firms because the program is voluntary years if the manufacturer does have a requirements. Testing and and the costs of adding or modifying a reasonable testing program. However, if recordkeeping required to comply with label on a product are expected to be fewer than 10,000 units of a product the more stringent rule would also meet low. have been manufactured or imported the requirements of the less stringent since the last time the product was 7. Summary of Impact on Small rule. Manufacturers will not be required Businesses to duplicate tests or recordkeeping to submitted to a third party conformity comply with both sets of rules. There assessment body, the manufacturer The proposed rule, if finalized, could would not be subject to the periodic have a significant adverse impact on a are no known Federal rules that conflict with the proposed rule. testing requirements unless 10,000 units substantial number of small businesses. have been manufactured or imported. The provisions of the proposed rule that 9. Alternatives for Reducing the Adverse This provision would allow low-volume are expected to have the most Impact on Small Businesses manufacturers to spread their periodic significant impact are provisions related testing costs over more units. The to requirements for the third party The Commission recognizes that the exemption would not relieve the testing of children’s products with and proposed rule could have a significant manufacturer from the obligation to without a reasonable testing program. and disproportionate impact on small have the product tested by a third party The impact of the proposed rule would and low-volume manufacturers. The conformity assessment body before the be expected to be disproportionate on Commission has incorporated some product is introduced into commerce, or small and low-volume manufacturers. provisions into the proposed rule that when there has been a material change This is because testing costs are are intended to lessen the impact on in the product’s design or production relatively fixed. Therefore, the per unit small businesses. These include some processes, nor would the exemption impact of testing costs will be greater on relief from the periodic testing low-volume producers than on high- requirement for children’s products, the extend beyond the initial exemption for volume producers. ability to use component part testing the first 10,000 units. The provisions of the proposed rule (which would be addressed by a b. Component Testing that would require manufacturers of separate Commission rule elsewhere in nonchildren’s products to establish and this issue of the Federal Register). The The proposed rule would allow firms maintain a reasonable testing program Commission invites comments on these to submit component parts for third also could have an adverse impact on provisions and other provisions or party testing when the required testing some manufacturers. The impact of alternatives that could lessen the does not need to be performed on the these provisions are expected to be less adverse impact on small or low-volume finished product. This can reduce the significant than the impact of the businesses. cost to manufacturers particularly where provisions related to children’s products The Commission is proposing that one component part might be common because many manufacturers are manufactures that have implemented to more than one product. Such believed to already have at least some reasonable testing programs that meet component parts might include paints, quality assurance or testing programs in the requirements contained in the polymers used in molding different place. The provisions related to the proposed rule would be obligated to parts, and standard-sized bolts. In these proposed requirement for a reasonable conduct third party periodic tests at cases the component parts might be testing program are intended to provide least once every two years instead of at received in larger lots than the manufacturers with a high degree of least once every year if they have not production lots of the products in which flexibility in designing and implemented reasonable testing they are used. Therefore, the testing implementing the programs, which programs. This provision could costs for those component parts will be would also serve to reduce the potential significantly reduce the third party spread over more units than if they were impact on a firm. periodic testing costs of manufacturers required to be tested on the finished The other requirements in the that have such programs. However, the products. proposed rule for protection against reduction could be limited for firms that do not have the ability to conduct the 10. Alternatives That May Further undue influence over a conformity Reduce the Impact on Small Businesses assessment body and the consumer tests in-house, for importers that do product labeling program are less likely have significant control over the actual The Commission also invites to have a significant adverse impact on production of their products, and for comments on other alternatives that a substantial number of small manufacturers who might have more could provide some relief to small businesses. The Commission invites frequent material changes in their businesses that would be adversely comments on these provisions. products’ designs, manufacturing impacted by the proposed rule. processes, or sourcing of component Alternatives could include things such 8. Federal Rules Which May Duplicate, parts. The Commission invites comment as: (1) The establishment of different Overlap, or Conflict With the Proposed on this provision, including whether compliance or reporting requirements Rule this provision would provide sufficient that take into account the resources The proposed rule would establish relief to enough firms to maintain this available to small businesses; (2) the the minimum requirements for testing provision in the final rule. clarification, consolidation, or

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simplification of compliance and with the applicable safety rules. E. Paperwork Reduction Act reporting requirements for small However, this would also increase the entities; (3) the use of performance costs associated with third party testing. This proposed rule contains information collection requirements that rather than design standards; and (4) an The Commission invites comments on are subject to public comment and exemption from coverage of the rule, or these and similar alternatives. For review by the Office of Management and any part of the rule thereof, for small example, should the Commission Budget (OMB) under the Paperwork entities to the extent statutorily consider a less stringent requirement? If Reduction Act of 1995 (44 U.S.C. 3501 permissible under section 14 of the so, what should the alternative through 3520). We describe the CPSA. In providing such comments, the requirement be? Should the less provisions in this section of the Commission requests that the comments stringent requirement apply to all document with an estimate of the provide specific suggestions and well manufacturers or only those that meet annual reporting burden. Our estimate developed justifications for the certain criteria, such as to small or low- includes the time for reviewing suggestions. Some possible alternatives volume manufacturers? that could be considered are discussed instructions, gathering and maintaining below. b. Limits on Third Party Testing for the data needed, and completing and Small or Low-Volume Manufacturers reviewing each collection of a. Less Stringent Requirements for Third information. Party Testing The Commission could consider additional alternatives that would We particularly invite comments on: The proposed rule would require that provide relief to small or low-volume (1) Whether the collection of enough third party tests be conducted to manufacturers. Substantial relief could information is necessary for the proper provide a high degree of assurance that be provided to small or low-volume performance of the CPSC’s functions, the products comply with the applicable manufacturers. The Commission invites including whether the information will rules. This could require most comments on third party testing limits have practical utility; (2) the accuracy of manufacturers to submit multiple for small or low-volume manufacturers the CPSC’s estimate of the burden of the samples for third party testing each that still meet statutory requirements of proposed collection of information, year, especially if they have not section 14(d) of the CPSA. In providing including the validity of the implemented a reasonable testing such comments, it is important to note methodology and assumptions used; (3) program. However, the Commission that the Commission cannot exempt ways to enhance the quality, utility, and could adopt an alternative that would clarity of the information to be limit the number of samples required for small or low-volume manufacturers of children’s products from initial third collected; and (4) ways to minimize the third party testing. For example, the burden of the collection of information Commission could simply require that party certification testing to applicable standards, regulations, or bans or from on respondents, including through the manufacturers submit sufficient samples use of automated collection techniques, to a third party conformity assessment third party testing when there is a material change to the product and has when appropriate, and other forms of body so that compliance with each rule information technology. could be assessed at least once annually. already specified limits on periodic The proposed rule would require that testing where a manufacturer produces Title: Testing and Labeling Pertaining periodic third party testing be less than 10,000 units of a particular to Product Certification. conducted at least once a year or at least product. The Commission seeks Description: The proposed rule would once every two years if the comments on additional alternatives implement section 102(b) of the CPSIA, manufacturer has established a that may provide testing cost relief to which requires certifications of reasonable testing program. A year was small or low-volume manufacturers compliance with safety standards for chosen as the maximum interval while still satisfying the testing and each product subject to a consumer between periodic testing because many compliance requirements of section product safety rule, ban, standard, or children’s products are produced on an 14(d) of the CPSA. regulation promulgated and/or enforced annual or seasonal cycle, but, in the c. Alternative Test Methods for Small or by the CPSC. A certification that a case of manufacturers with reasonable Low-Volume Manufacturers nonchildren’s product complies with testing programs, the Commission applicable consumer products safety believed that the information about the Some small manufacturers have rules, bans, standards, and regulations products provided the manufacturer by encouraged the Commission to allow must be supported by a reasonable the internal testing programs could alternative test methods such as those testing program or a test of each substitute for some third party tests. The relying on XRF technology. XRF testing product. A certification that a children’s Commission could, however, consider a methods are significantly less expensive product complies with the applicable different maximum interval between the than the ICP analysis that the children’s product safety rules must be periodic tests. For example, the Commission currently requires for most supported by testing performed by an Commission could consider requiring lead content testing (with the exception approved third party conformity that third party tests be conducted at of homogenous polymer products). The assessment body. The proposed rule less frequent or more frequent intervals. Commission staff uses XRF for would impose recordkeeping The advantage of less stringent screening samples. requirements related to those testing requirements is that they could The Commission invites comments on and certification requirements. The significantly reduce the cost of the third the possibility of using alternative recordkeeping requirements are party testing requirement. The testing technologies for reducing the intended to allow one to uniquely disadvantage is that the testing would burden on small and low-volume identify each product and establish that provide less information about whether manufacturers. For example, could the it was properly certified before it enters all of the products produced were in Commission allow small or low-volume commerce and has been properly compliance with the applicable safety manufacturers to use less expensive, but retested for conformity with all rules. Requiring third party tests more potentially less accurate third party applicable rules on a continuing basis, frequently would provide additional testing methods? If so, under what including after a material change in the assurance that the products comply conditions? product’s design or manufacturing

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processes, including the sourcing of the product and the amount of testing is the total hourly compensation for component parts. that must be documented. CPSC staff private sector workers in management, Each manufacturer or importer of a does not have comprehensive data on professional, and related occupations. consumer product subject to an the universe of products that will be The recordkeeping requirements are not applicable safety rule would be required impacted. Therefore, estimates of the expected to result in any additional cost to establish and maintain the following hour burden of the recordkeeping to the Federal government. The CPSC records: requirements are somewhat speculative. will likely request access to these • A copy of the certificate of The CPSC invites comments that can records only when it is investigating compliance for each product. In the case provide more information about the potentially defective or noncomplying of nonchildren’s products, the required number of hours required for the products. Investigating potentially certificate is a general conformity recordkeeping requirements of the defective or noncomplying product is a certificate. In the case of children’s proposed rule. regular ongoing activity of the products, the certificate must be based Previously, the CPSC staff estimated Commission. It is anticipated that access upon testing by a third party conformity that the recordkeeping burden of the to the records required by this rule will assessment body. (Proposed mattress open flame flammability make it easier for the investigators to §§ 1107.10(a)(5)(i)(A), 1107.26(a)(1)) standard would be about one hour per narrow the scope of their investigations • For nonchildren’s products, a model (prototype) per year. Many of the to particular production or import lots. record of each product specification, recordkeeping requirements in that In compliance with the Paperwork including any new product specification standard are comparable to the Reduction Act of 1995 (44 U.S.C. resulting from remedial action. requirements in this proposed rule. 3507(d)), we have submitted the (Proposed § 1107.10(a)(5)(i)(B) and (E)) However, that rule concerned only the information collection requirements of • Records of each certification test, recordkeeping requirements for one rule this rule to OMB for review. Interested including identification of the third (mattress flammability) while persons are requested to fax comments party conformity assessment body, if manufacturers of children’s products regarding information collection by June any, that conducted the test. (Proposed will frequently have to document their 21, 2010, to the Office of Information §§ 1107.10(a)(5)(i)(C), 1107.26(a)(2)) compliance with more than one product • and Regulatory Affairs, OMB (see Records of the production testing safety rule (e.g., lead-in-paint, lead ADDRESSES). and periodic test plans and results. content, phthalates, and some product (Proposed §§ 1107.10(a)(5)(i)(D), specific rules, such as the ASTM F963 F. Environmental Considerations 1107.26(a)(3)) toy standard). Therefore, one can This proposed rule falls within the • For children’s products, records assume the burden of the proposed rule scope of the Commission’s relating to all material changes. could be twice the hour burden of the environmental review regulations at 16 (Proposed § 1107.26(a)(4)) recordkeeping required for the mattress CFR 1021.5(c)(2) which provides a • Records of all remedial actions flammability rule. (Information on the categorical exclusion from any taken. (Proposed §§ 1107.10(a)(5)(i)(E), product safety rules that apply to requirement for the agency to prepare an 1107.26(a)(6)) different consumer products can be • environmental assessment or For children’s products, records of found at http://www.cpsc.gov/businfo/ environmental impact statement for undue influence procedures. (Proposed regsbyproduct.html.) product certification rules. § 1107.26(a)(5)) According to a representative of a Description of Respondents: The trade association, there are an estimated G. Executive Order 12988 recordkeeping requirements contained 50,000 to 60,000 individual toys on the Executive Order 12988 (February 5, in this proposed rule would apply to all market. It is likely that there are at least 1996), requires agencies to state in clear manufacturers or importers of consumer that many other children’s products in language the preemptive effect, if any, of products that are covered by one or product categories such as wearing new regulations. The proposed more consumer product safety rules apparel, accessories, jewelry, juvenile regulation would be issued under promulgated and/or enforced by the products, children’s furniture, etc. authority of the CPSA and the CPSIA. CPSC. The CPSC reviewed every Additionally nonchildren’s products The CPSA provision on preemption category in the NAICS and selected that are subject to product safety rules appears at section 26 of the CPSA. The those that included firms that could include paints, nonmetal furniture (for CPSIA provision on preemption appears manufacture or sell any consumer lead-in-paint), all-terrain vehicles, at section 231 of the CPSIA. The product that could be covered by a bicycles, and bunk beds. Therefore, we preemptive effect of this rule would be consumer product safety rule. Using estimate that there are approximately determined in an appropriate data from the U.S. Census Bureau, we 100,000 to 150,000 individual products proceeding in by a court of competent determined that there were over 37,000 to which the recordkeeping jurisdiction. manufacturers, almost 80,000 requirements would apply. wholesalers, and about 128,000 retailers Assuming the annual recordkeeping H. Effective Date in these categories. However, not all of burden per product will be two hours The Commission is proposing that the firms in these categories and that there are between 100,000 and any final rule based on this proposal manufacture or import products that are 150,000 products to which the become effective 180 days after its date covered by consumer product safety recordkeeping requirements would of publication in the Federal Register. rules. Therefore, these numbers would apply, the total hour burden for the constitute a high estimate of the number recordkeeping requirements is estimated List of Subjects in 16 CFR Part 1107 of firms that are subject to the to be between 200,000 and 300,000 Business and industry, Children, recordkeeping requirements. hours. Consumer protection, Imports, Product Estimate of the Burden: The hour The total cost burden of the testing and certification, Records, burden of the recordkeeping recordkeeping requirements is expected Record retention, Toys. requirements will likely vary greatly to be between $9.8 and $14.7 million. Accordingly, the Commission from product to product depending This estimate is obtained by multiplying proposes to add 16 CFR part 1107 to upon such factors as the complexity of the total burden hours by $48.91, which read as follows:

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PART 1107—TESTING AND LABELING High degree of assurance means an (i) A product specification must PERTAINING TO PRODUCT evidence-based demonstration of include any component parts that are CERTIFICATION consistent performance of a product certified pursuant to 16 CFR Part 1109. regarding compliance based on (ii) Product specifications that Subpart A—General Provisions knowledge of a product and its identify individual features of a product Sec. manufacture. that would not be considered a material 1107.1 Purpose. Identical in all material respects change may use the same product 1107.2 Definitions. means there is no difference with specification for all products Subpart B—Reasonable Testing Program respect to compliance to the applicable manufactured with those specific for Nonchildren’s Products rules between the samples and the features. Features that would not be 1107.10 Reasonable testing program for finished product. considered a material change include nonchildren’s products. Manufacturer means the parties different product sizes or other features responsible for certification of a that cover variations of the product Subpart C—Certification of Children’s where those variations do not affect the Products consumer product pursuant to 16 CFR part 1110. product’s ability to comply with 1107.20 General requirements. Manufacturing process means the applicable rules, bans, standards, or 1107.21 Periodic testing. techniques, fixtures, tools, materials, regulations. 1107.22 Random samples. (iii) Each manufacturing site must 1107.23 Material change. and personnel used to create the 1107.24 Undue influence. component parts and assemble a have a separate product specification. 1107.25 Remedial action. finished product. (2) Certification Tests. A manufacturer 1107.26 Recordkeeping. Production testing plan means a must conduct certification tests on a document that shows what tests must be product before issuing a general Subpart D—Consumer Product Labeling conformity certificate for that product. Program performed and the frequency at which those tests must be performed to A certification test is a test performed 1107.40 Labeling consumer products to provide a high degree of assurance that on samples of the product that are indicate that the certification the products manufactured after identical to the finished product in all requirements of section 14 of the CPSA material respects to demonstrate that the have been met. certification continue to meet all the applicable safety rules. product complies with the applicable Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. Third party conformity assessment safety rules, bans, standards, or L. 110–314, 122 Stat. 3016, 3017, 3022. body means a third party conformity regulations. Certification tests must contain the following elements: Subpart A—General Provisions assessment body recognized by the CPSC to conduct certification testing on (i) Samples. For purposes of this § 1107.1 Purpose. children’s products. section, a sample means a component This part establishes the requirements part of the product or the finished for: A reasonable testing program for Subpart B—Reasonable Testing product which is subject to testing. nonchildren’s products; third party Program for Nonchildren’s Products Samples submitted for certification conformity assessment body testing to testing must be identical in all material § 1107.10 Reasonable testing program for respects to the product to be distributed support certification and continuing nonchildren’s products. testing of children’s products; and in commerce. The manufacturer must (a) Except as otherwise provided in a labeling of consumer products to submit a sufficient number of samples specific regulation under this title or a indicate that the certification for certification testing so as to provide specific standard prescribed by law, a requirements have been met pursuant to a high degree of assurance that the manufacturer certifying a product sections 14(a)(1), and (a)(2), (d)(2)(B) of certification tests accurately represent pursuant to a reasonable testing program the Consumer Product Safety Act the product’s compliance with all must ensure that the reasonable testing (CPSA) (15 U.S.C. 2063(a)(1), (a)(2), applicable rules. program provides a high degree of (d)(2)(B)). (A) Only finished products or assurance that the consumer products component parts listed on the product § 1107.2 Definitions. covered by the program will comply specification can be submitted for Unless otherwise stated, the with all applicable rules, bans, certification testing. definitions of the Consumer Product standards, or regulations. (B) A manufacturer may substitute Safety Act and the Consumer Product (b) A reasonable testing program must component part testing for finished Safety Improvement Act of 2008 apply consist of the following elements: product testing pursuant to 16 CFR part to this part. The following definitions (1) Product Specification. The product 1109 unless the rule, ban, standard or apply for purposes of this part: specification is a description of the regulation applicable to the product CPSA means the Consumer Product consumer product and lists the requires testing of the finished product. Safety Act. applicable rules, bans, standards or If a manufacturer relies upon CPSC means the Consumer Product regulations to which the product is certification testing of component Safety Commission. subject. A product specification should part(s) (rather than tests of the finished Detailed bill of materials means a list describe the product listed on a general product), the manufacturer must of the raw materials, sub-assemblies, conformity certification in sufficient demonstrate how the combination of intermediate assemblies, sub- detail to identify the product and testing of component part(s), portions of component parts, component parts, and distinguish it from other products made the finished product, and finished the quantities of each needed to by the manufacturer. The product product samples demonstrate, with a manufacture a finished product. specification may include, but is not high degree of assurance, compliance Due care means the degree of care that limited to, a color photograph or with all applicable rules, bans, a prudent and competent person illustration, model names or numbers, a standards, or regulations. engaged in the same line of business or detailed bill of materials, a parts listing, (ii) Material Change. A material endeavor would exercise under similar raw material selection and sourcing change is any change in the product’s circumstances. requirements. design, manufacturing process, or

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sourcing of component parts that a (iii) The production testing interval specification can be certified as manufacturer exercising due care selected must be short enough to ensure compliant with the applicable rules, knows, or should know, could affect the that, if the samples selected for bans, standards, or regulations, a product’s ability to comply with the production testing comply with an manufacturer must have passing applicable rules, bans, standards, or applicable rule, ban, standard, or certification test results for the regulations. regulation, there is a high degree of applicable rules, bans, standards, or (A) When a previously-certified assurance that the untested products regulation. product undergoes a material change manufactured during that interval also (5) Recordkeeping. that only affects the product’s ability to will comply with the applicable rule, (i) A manufacturer of a nonchildren’s comply with certain applicable rules, ban, standard, or regulation. Production product must maintain the following bans, standards, or regulations, test intervals should be appropriate for records: certification for the new product the specific testing or alternative (A) Records of the general conformity specification may be based on measurements being conducted. certificate for each product; certification testing of the materially (A) A manufacturer may use (B) Records of each product changed component part, material, or measurement techniques that are specification; process, and the passing certification nondestructive and tailored to the needs (C) Records of each certification test tests of the portions of the previously- of an individual product instead of and, if the manufacturer elected to have certified product that were not conducting product performance tests to a third party conformity assessment materially changed. assure a product complies with all body test the product, identification of (B) A manufacturer must conduct applicable rules, bans, standards, or any third party conformity assessment certification tests of the finished regulations. body on whose testing the certificate product if a material change affects the (B) Any production test method used depends. Records of certification tests finished product’s ability to comply to conduct production testing must be must describe how the product was with an applicable rule, ban, standard, as effective in detecting noncompliant certified as meeting the requirements, or regulation. products as the tests used for (C) A manufacturer must exercise due including how each applicable rule was certification. evaluated, the test results, and the care to ensure that reliance on anything (C) If a manufacturer is uncertain actual values of the tests; other than retesting of the finished whether a production test is as effective (D) Records to demonstrate product after a material change occurs as the certification test, the compliance with the production testing does not allow a noncompliant product manufacturer must use the certification plan requirement, including a list of the to be distributed in commerce. A test. manufacturer should resolve any doubts (4) Remedial Action Plan. applicable rules, bans, standards, or in favor of retesting the finished product (i) A remedial action plan describes regulations, a description of the types of for certification. the steps to be taken whenever samples production tests conducted, the number (3) Production Testing Plan. A of a product or a component part of a of samples tested, the production production testing plan describes what product fails a test or fails to comply interval selected for performance of tests must be performed and the with an applicable rule, ban, standard, each test, and the test results. Records frequency at which those tests must be or regulation. A remedial action plan of a production test program must performed to provide a high degree of must contain procedures the describe how the production tests assurance that the products manufacturer must follow to investigate demonstrate that the continuing manufactured after certification and address failing test results. production complies with the continue to meet all the applicable Manufacturers must take remedial applicable rules. References to safety rules, bans, standards, or action after any failing test result to techniques in relevant quality regulations. A production testing plan ensure with a high degree of assurance management and control standards, may include recurring testing or the use that the products manufactured after the such as ANSI/ISO/ASQ Q9001–2008: of process management techniques such remedial action has been taken comply Quality management systems— as control charts, statistical process with the applicable rules, bans, Requirements, ANSI/ASQ Z1.4–2008: control programs, or failure modes and standards, or regulations. The type of Sampling Procedures and Tables for effects analyses (FMEAs) designed to remedial action may be different Inspection by Attributes, and/or ANSI/ control potential variations in product depending upon the applicable rule, ASQ Z1.9–2008: Sampling Procedures manufacturing that could affect the ban, standard, or regulation. Remedial and Tables for Inspection by Variables product’s ability to comply with the action can include, but is not limited to: for Percent Nonconforming, may be applicable rules, bans, standards, or (A) Changes to the manufacturing used to demonstrate that the production regulations. A production testing plan process, the equipment used to tests have the necessary accuracy, must contain the following elements: manufacture the product, the product’s precision sensitivity, repeatability, and (i) A description of the production materials, or design; confidence to distinguish between testing plan, including, but not limited (B) reworking the product produced; compliant and noncompliant products; to, a description of the tests to be or (E) Records of all remedial actions conducted or the measurements to be (C) other actions deemed appropriate taken, including the specific action taken, the intervals at which the tests or by the manufacturer, in the exercise of taken, the date the action was taken, the measurements will be made, the number due care, to assure compliant products. person who authorized the actions, and of samples tested, and the basis for (ii) Any remedial action that results in any test failure which necessitated the determining that such tests provide a a material change to a product’s design, action. Records of remedial action must high degree of assurance of compliance parts, suppliers of parts, or relate the action taken to the product if they are not the tests prescribed in the manufacturing process that could affect specification of the product that was the applicable rule, ban, standard, or the product’s ability to comply with any subject of that remedial action and the regulation; applicable rules requires a new product product specification of any new (ii) Each manufacturing site must specification for that product. Before a product resulting from any remedial have a separate production testing plan; product covered by the new product action;

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(ii) If a remedial action results in a children’s products, a manufacturer may children’s product certification, or when new product specification, the need to submit more samples to provide the previous periodic testing was manufacturer must create a new set of a high degree of assurance that the conducted, continue to comply with all records for the product. finished product complies with the applicable children’s product safety (iii) A manufacturer must maintain applicable children’s product safety rules. The periodic test plan must the records specified in this subpart at rules. include the tests to be conducted, the the location within the United States (c) Except where otherwise specified intervals at which the tests will be specified in 16 CFR 1110.11(d) or, if the by a children’s product safety rule, a conducted, the number of samples records are not maintained at the manufacturer may substitute component tested, and the basis for determining custodian’s address, at a location within part testing for complete product testing that the periodic testing plan provides a the United States specified by the pursuant to 16 CFR part 1109 if the high degree of assurance that the custodian. The manufacturer must make component part, without the remainder product being tested continues to these records available, either in hard of the finished product, is sufficient to comply with all applicable children’s copy or electronically, for inspection by determine compliance for the entire product safety rules. The manufacturer the CPSC upon request. product. must have a separate periodic testing (iv) A manufacturer must maintain (d) If a product sample fails plan for each manufacturing site records (except for test records) for as certification testing, even if other producing a children’s product. long as the product is in production or samples have passed the same (2) Testing Interval. The periodic imported by the manufacturer plus five certification test, the manufacturer must testing interval selected must be short years. Test records must be maintained investigate the reasons for the failure enough to ensure that, if the samples for five years. All records must be and take remedial action. A selected for periodic testing pass the available in the English language. manufacturer cannot certify the test, there is a high degree of assurance (c) If any certification test results in a children’s product until the that the other untested children’s failure, a manufacturer cannot certify a manufacturer establishes, with a high products manufactured during the product until the manufacturer has degree of assurance, that the finished interval comply with the applicable taken remedial action, and the product product does comply with all applicable children’s product safety rules. The manufactured after the remedial action children’s product safety rules. interval for periodic testing may vary passes certification testing. depending upon the specific children’s § 1107.21 Periodic testing. (d) Manufacturers of a nonchildren’s product safety rules that apply to the product may use a third party (a) Each manufacturer must conduct children’s product. Factors to be conformity assessment body to conduct periodic testing at least annually, except considered when determining the certification testing but are not required as otherwise provided in paragraphs (b) periodic testing interval include, but are to use a third party conformity and (d) of this section or as provided in not limited to, the following: assessment body recognized by the regulations under this title. (i) High variability in test results, as CPSC to conduct certification testing on Manufacturers may need to conduct indicated by a relatively large sample children’s products. periodic tests more frequently than on standard deviation in quantitative tests; (e) Manufacturers of children’s an annual basis to ensure a high degree (ii) Measurements that are close to the products may voluntarily establish a of assurance that the product being allowable numerical limit for reasonable testing program consistent tested complies with all applicable quantitative tests; with this subpart. children’s product safety rules. (iii) Known manufacturing process (b) If a manufacturer has implemented factors which could affect compliance Subpart C—Certification of Children’s a reasonable testing program as with a rule. For example, if the Products described in subpart B of this part, it manufacturer knows that a casting die must submit samples of its product to a wears down as the die nears the end of § 1107.20 General requirements. third party conformity assessment body its useful life, the manufacturer may (a) Manufacturers must submit a for periodic testing to the applicable wish to test more often as the casting die sufficient number of samples of a children’s product safety rules at least wears down; children’s product, or samples that are once every two years. If a (iv) Consumer complaints or warranty identical in all material respects to the manufacturer’s reasonable testing claims; children’s product, to a third party program fails to provide a high degree (v) Nonmaterial changes, such as conformity assessment body for testing of assurance of compliance with all introduction of a new set of component to support certification. The number of applicable children’s product safety parts into the assembly process, or the samples selected must provide a high rules, the Commission may require the manufacture of a fixed number of degree of assurance that the tests manufacturer to meet the requirements products; conducted for certification purposes of paragraph (c) of this section or (vi) Potential for serious injury or accurately demonstrate the ability of the modify its reasonable testing program to death resulting from a noncompliant children’s product to meet all applicable ensure a high degree of assurance. children’s product; children’s product safety rules. (c) If a manufacturer has not (vii) The number of children’s (b) If the manufacturing process for a implemented a reasonable testing products produced annually, such that children’s product consistently creates program as described in subpart B of a manufacturer should consider testing finished products that are uniform in this part, then all periodic testing must a children’s product more frequently if composition and quality, a be conducted by a third party the product is produced in very large manufacturer may submit fewer samples conformity assessment body, and the numbers or distributed widely to provide a high degree of assurance manufacturer must conduct periodic throughout the United States; that the finished product complies with testing as follows: (viii) The children’s product’s the applicable children’s product safety (1) Periodic Test Plan. Manufacturers similarity to other children’s products rules. If the manufacturing process for a must develop a periodic test plan to with which the manufacturer is familiar children’s product results in variability assure that children’s products and/or whether the children’s product in the composition or quality of manufactured after the issuance of a has many different component parts

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compared to other children’s products not affect the ability of the children’s exercise of undue influence by a of a similar type; or product to comply with other applicable manufacturer on a third party (ix) Inability to determine the children’s product safety rules, a conformity assessment body. children’s product’s noncompliance manufacturer may issue a children’s (b) The procedures required in easily through means such as visual product certificate based on the earlier paragraph (a) of this section, at a inspection. third party certification tests and on test minimum, must include: (d) For a product produced or results of the changed component part (1) Safeguards to prevent attempts by imported at low volumes, a conducted by a third party conformity the manufacturer to exercise undue manufacturer is not subject to the assessment body. Changes that cause a influence on a third party conformity periodic testing requirements of children’s product safety rule to no assessment body, including a written paragraphs (a) and (b) or (c) of this longer apply to a children’s product are policy statement from company officials section unless it produces 10,000 units not considered to be material changes. that the exercise of undue influence is of the product. Once a manufacturer has A manufacturer must exercise due care not acceptable, and directing that produced or imported 10,000 units of to ensure that reliance on anything other appropriate staff receive annual training the product, the frequency at which the than retesting of the finished product on avoiding undue influence, and sign manufacturer must engage in periodic after a material change would not allow testing must comply with paragraph (a), a noncompliant children’s product to be a statement attesting to participation in and (b) or (c) of this section and does distributed in commerce. A such training; not depend on how often the manufacturer should resolve any doubts (2) A requirement to notify the manufacturer produces or imports every in favor of retesting the finished product Commission immediately of any attempt 10,000 units of the product. for certification. Additionally, a by the manufacturer to hide or exert manufacturer must exercise due care to undue influence over test results; and § 1107.22 Random samples. ensure that any component part (3) A requirement to inform Each manufacturer must select undergoing component-part-level employees that allegations of undue samples for periodic testing by using a testing is the same as the component influence may be reported process that assigns each sample in the part on the finished children’s product confidentially to the Commission and to production population an equal in all material respects. describe the manner in which such a probability of being selected. For (b) Product Design. For purposes of report can be made. purposes of this section, the production this subpart, the term product design population is the number of products includes all component parts, their § 1107.25 Remedial action. manufactured or imported after the composition, and their interaction and (a) Each manufacturer of a children’s initial certification or last periodic functionality when assembled. To product must have a remedial action testing of a children’s product. A determine which children’s product plan that contains procedures the manufacturer may use a procedure that safety rules apply to a children’s manufacturer must follow to investigate randomly selects items from a list to product, a manufacturer should and address failing test results. A determine which samples are the examine the product design for the manufacturer must take remedial action random samples used for periodic children’s product as received by the after any failing test result to ensure, testing before production begins. A consumer. with a high degree of assurance, that the manufacturer may select samples for (c) Manufacturing Process. A material children’s products manufactured after testing as they are manufactured. change in the manufacturing process is the remedial action has been taken Manufacturers who produce children’s a change in how the children’s product comply with all applicable children’s products that continue to be distributed is made that could affect the finished product safety rules. in commerce as they are manufactured children’s product’s ability to comply (b) A manufacturer must not certify a may wish to test the samples as they with the applicable children’s product product if any certification test by a become available instead of waiting safety rules. For each change in the third party conformity assessment body until all the random samples have been manufacturing process, a manufacturer results in a failure until the selected before conducting testing. should exercise due care to determine if manufacturer has taken remedial action compliance to an existing applicable § 1107.23 Material change. and the product manufactured after the children’s product safety rule could be (a) General Requirements. If a remedial action passes certification affected, or if the change results in a testing. children’s product undergoes a material newly-applicable children’s product change in product design or safety rule. (c) Following a failing test result, a manufacturing process, including the (d) Sourcing of Component Parts. A manufacturer must take remedial action sourcing of component parts, that a material change in the sourcing of to ensure, with a high degree of manufacturer exercising due care component parts results when the assurance, that the children’s product knows, or should know, could affect the replacement of one component part of a complies with all applicable children’s product’s ability to comply with the children’s product with another product safety rules. Remedial action applicable children’s product safety component part could affect compliance can include, but is not limited to, rules, the manufacturer must submit a with the applicable children’s product redesign, changes in the manufacturing sufficient number of samples of the safety rules. This includes, but is not process, or changes in component part materially changed product for testing limited to, changes in component part sourcing. For existing production, by a third party conformity assessment composition, component part supplier, remedial action may include rework, body. Such testing must occur before a or the use of a different component part repair, or scrap of the children’s manufacturer can certify the children’s from the same supplier who provided product. If a remedial action results in product. The extent of such testing may the initial component part. a material change a manufacturer must depend on the nature of the material have a third party conformity change. When a material change is § 1107.24 Undue influence. assessment body retest the redesigned or limited to a component part of the (a) Each manufacturer must establish remanufactured product before the finished children’s product and does procedures to safeguard against the manufacturer can certify the product.

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§ 1107.26 Recordkeeping. results from certification tests showing standard or regulation under any other (a) A manufacturer of a children’s compliance after the remedial action act enforced by the CPSC. product subject to an applicable was taken. (b) The label must be printed in bold children’s product safety rule must (b) A manufacturer must maintain the typeface, using an Arial font of not less maintain the following records: records specified in this subpart at the than 12 points, be visible and legible, (1) Records of the children’s product location within the United States and consist of the following statement: certificate for each product. The specified in 16 CFR 1110.11(d) or, if the Meets CPSC Safety Requirements children’s product covered by the records are not maintained at the (c) A consumer product may bear the certificate must be clearly identifiable custodian’s address, at a location within label if the manufacturer or private and distinguishable from other the United States specified by the labeler has certified, pursuant to section products; custodian. The manufacturer must make 14 of the CPSA, that the consumer (2) Records of each third party these records available, either in hard product complies with all applicable certification test. The manufacturer copy or electronically, for inspection by consumer product safety rules under the must have separate certification tests the CPSC upon request. CPSA and with all rules, bans, records for each manufacturing site; (c) A manufacturer must maintain standards, or regulations applicable to (3) Records of the periodic test plan records (except for test records) for as the product under any other act and periodic test results for a children’s long as the product is in production or enforced by the Consumer Product product; imported by the manufacturer plus five Safety Commission. (4) Records of descriptions of all years. Test records must be maintained material changes in product design, for five years. All records must be (d) A manufacturer or private labeler manufacturing process, and sourcing of available in the English language. may use another label on the consumer component parts, and the certification product as long as such label does not tests run and the test values; Subpart D—Consumer Product alter or mislead consumers as to the (5) Records of the undue influence Labeling Program meaning of the label described in procedures, including training materials paragraph (b) of this section. A and training records of all employees § 1107.40 Labeling consumer products to manufacturer or private labeler must not trained on these procedures; and indicate that the certification requirements imply that the CPSC has tested, of section 14 of the CPSA have been met. (6) Records of all remedial actions approved, or endorsed the product. taken following a failing test result, (a) Manufacturers and private labelers including the rule that was tested, the of a consumer product may indicate, by Dated: May 7, 2010. specific remedial action taken, the date a uniform label on or provided with the Todd A. Stevenson, the action was taken, the person who product, that the product complies with Secretary. authorized the action, any test failure any consumer product safety rule under [FR Doc. 2010–11365 Filed 5–19–10; 8:45 am] which necessitated the action, and the the CPSA, or with any similar rule, ban, BILLING CODE 6355–01–P

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